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Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF) (BLOCK HF)

Primary Purpose

Atrioventricular Block, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy (CRT)
Cardiac Resynchronization Therapy (CRT)
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Block focused on measuring Atrioventricular block, Cardiac Resynchronization Therapy, Pacemaker, Defibrillator, NYHA Class I, II or III Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked Subject is receiving first time implant Subjects with heart failure but no symptoms of it (New York Heart Association [NYHA] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III) Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days Subject is at least 18 years old Subject or authorized legal guardian or representative has signed and dated the Informed Consent Subject is able to receive a pectoral implant Subject is expected to remain available for follow-up visits at the study center Subject is willing and able to comply with the protocol Exclusion Criteria: Subject has ever had a previous or has an existing device implant Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days Subjects with coronary bypass within the past 30 days Subjects with stent within the past 30 days Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement Subjects with a mechanical right heart valve Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices) Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager) Subject is pregnant, or of child bearing potential and not on a reliable form of birth control Subjects with a previous heart transplant Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting) Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biventricular pacing

Right ventricular pacing

Arm Description

Outcomes

Primary Outcome Measures

Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.

Secondary Outcome Measures

All-Cause Mortality
The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared. This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met).
All-Cause Mortality or Heart Failure-related Hospitalization
The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index
The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization. Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive.
First Heart Failure Hospitalization
The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.
Days Hospitalized for Heart Failure
For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.
Change in New York Heart Association Classification
The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.
Change in Heart Failure Stage
The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.
Change in Cardiovascular Medications
The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)
Frequency of Adverse Events Post-randomization
Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.
Cardiovascular-related Healthcare Utilizations
Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm
Change in Quality of Life at 6 Months
The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Change in Quality of Life at 12 Months
The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Change in Quality of Life at 18 Months
The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Change in Quality of Life at 24 Months
The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Change in Mitral Regurgitation From Randomization to 6 Months
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Change in Mitral Regurgitation From Randomization to 12 Months
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Change in Mitral Regurgitation From Randomization to 18 Months
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Change in Mitral Regurgitation From Randomization to 24 Months
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Change in Cardiac Index From Randomization to 6 Months
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.
Change in Cardiac Index From Randomization to 12 Months
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.
Change in Cardiac Index From Randomization to 18 Months
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.
Change in Cardiac Index From Randomization to 24 Months
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Clinical Composite Score at 6 Months
The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Clinical Composite Score at 12 Months
The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Clinical Composite Score at 18 Months
The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Clinical Composite Score at 24 Months
The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
CRT-P and CRT-D System Implant Success
The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.
Incidence of Ventricular Tachyarrhythmias
Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.

Full Information

First Posted
December 19, 2005
Last Updated
February 20, 2014
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00267098
Brief Title
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Acronym
BLOCK HF
Official Title
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will: decrease the number of hospital and clinic visits due to heart failure symptoms extend life delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block, Heart Diseases
Keywords
Atrioventricular block, Cardiac Resynchronization Therapy, Pacemaker, Defibrillator, NYHA Class I, II or III Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
918 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biventricular pacing
Arm Type
Experimental
Arm Title
Right ventricular pacing
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy (CRT)
Other Intervention Name(s)
Medtronic CRT-P, Medtronic CRT-D
Intervention Description
Biventricular pacing
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy (CRT)
Other Intervention Name(s)
Medtronic CRT-P, Medtronic CRT-D
Intervention Description
Right ventricular pacing
Primary Outcome Measure Information:
Title
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
Description
Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Secondary Outcome Measure Information:
Title
All-Cause Mortality
Description
The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared. This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met).
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
All-Cause Mortality or Heart Failure-related Hospitalization
Description
The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index
Description
The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization. Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
First Heart Failure Hospitalization
Description
The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
Days Hospitalized for Heart Failure
Description
For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
Change in New York Heart Association Classification
Description
The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.
Time Frame
Randomization to 24 Months
Title
Change in Heart Failure Stage
Description
The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.
Time Frame
Randomization to 24 Months
Title
Change in Cardiovascular Medications
Description
The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
Frequency of Adverse Events Post-randomization
Description
Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
Cardiovascular-related Healthcare Utilizations
Description
Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm
Time Frame
Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Title
Change in Quality of Life at 6 Months
Description
The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Time Frame
Randomization to 6 Months
Title
Change in Quality of Life at 12 Months
Description
The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Time Frame
Randomization to 12 months
Title
Change in Quality of Life at 18 Months
Description
The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Time Frame
Randomization to 18 Months
Title
Change in Quality of Life at 24 Months
Description
The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life. Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months
Description
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months
Description
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months
Description
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months
Description
The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months
Description
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months
Description
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months
Description
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months
Description
The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months
Description
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months
Description
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months
Description
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months
Description
The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months
Description
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months
Description
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months
Description
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months
Description
The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months
Description
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months
Description
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months
Description
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months
Description
The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame
Randomization to 24 Months
Title
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months
Description
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame
Randomization to 6 Months
Title
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months
Description
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame
Randomization to 12 Months
Title
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months
Description
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame
Randomization to 18 Months
Title
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months
Description
The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame
Randomization to 24 Months
Title
Change in Mitral Regurgitation From Randomization to 6 Months
Description
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame
Randomization to 6 Months
Title
Change in Mitral Regurgitation From Randomization to 12 Months
Description
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame
Randomization to 12 Months
Title
Change in Mitral Regurgitation From Randomization to 18 Months
Description
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame
Randomization to 18 Months
Title
Change in Mitral Regurgitation From Randomization to 24 Months
Description
The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame
Randomization to 24 Months
Title
Change in Cardiac Index From Randomization to 6 Months
Description
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.
Time Frame
Randomization to 6 Months
Title
Change in Cardiac Index From Randomization to 12 Months
Description
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.
Time Frame
Randomization to 12 Months
Title
Change in Cardiac Index From Randomization to 18 Months
Description
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.
Time Frame
Randomization to 18 Months
Title
Change in Cardiac Index From Randomization to 24 Months
Description
The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.
Time Frame
Randomization to 24 Months
Title
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months
Description
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.
Time Frame
Randomization to 6 Months
Title
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months
Description
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.
Time Frame
Randomization to 12 Months
Title
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months
Description
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.
Time Frame
Randomization to 18 Months
Title
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months
Description
The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.
Time Frame
Randomization to 24 Months
Title
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months
Description
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame
Randomization to 6 Months
Title
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months
Description
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame
Randomization to 12 Months
Title
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months
Description
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame
Randomization to 18 Months
Title
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months
Description
The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame
Randomization to 24 Months
Title
Clinical Composite Score at 6 Months
Description
The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame
Randomization to 6 Months
Title
Clinical Composite Score at 12 Months
Description
The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame
Randomization to 12 Months
Title
Clinical Composite Score at 18 Months
Description
The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame
Randomization to 18 Months
Title
Clinical Composite Score at 24 Months
Description
The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame
Randomization to 24 Months
Title
CRT-P and CRT-D System Implant Success
Description
The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.
Time Frame
Initial Implant Procedure
Title
Incidence of Ventricular Tachyarrhythmias
Description
Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.
Time Frame
Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked Subject is receiving first time implant Subjects with heart failure but no symptoms of it (New York Heart Association [NYHA] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III) Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days Subject is at least 18 years old Subject or authorized legal guardian or representative has signed and dated the Informed Consent Subject is able to receive a pectoral implant Subject is expected to remain available for follow-up visits at the study center Subject is willing and able to comply with the protocol Exclusion Criteria: Subject has ever had a previous or has an existing device implant Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days Subjects with coronary bypass within the past 30 days Subjects with stent within the past 30 days Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement Subjects with a mechanical right heart valve Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices) Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager) Subject is pregnant, or of child bearing potential and not on a reliable form of birth control Subjects with a previous heart transplant Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting) Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne B. Curtis, MD, FHRS, FACC
Organizational Affiliation
University at Buffalo, NY
Official's Role
Principal Investigator
Facility Information:
City
Anchorage
State/Province
Alaska
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Hollywood
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
City
Rockford
State/Province
Illinois
Country
United States
City
Davenport
State/Province
Iowa
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Lacombe
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Grand Rapids
State/Province
Michigan
Country
United States
City
Petoskey
State/Province
Michigan
Country
United States
City
Ypsilanti
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis Park
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Camden
State/Province
New Jersey
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Ridgewood
State/Province
New Jersey
Country
United States
City
Bay Shore
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
West Islip
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Danville
State/Province
Pennsylvania
Country
United States
City
Doylestown
State/Province
Pennsylvania
Country
United States
City
Ephrata
State/Province
Pennsylvania
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Wynnewood
State/Province
Pennsylvania
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Kitchener
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27151347
Citation
Curtis AB, Worley SJ, Chung ES, Li P, Christman SA, St John Sutton M. Improvement in Clinical Outcomes With Biventricular Versus Right Ventricular Pacing: The BLOCK HF Study. J Am Coll Cardiol. 2016 May 10;67(18):2148-2157. doi: 10.1016/j.jacc.2016.02.051.
Results Reference
derived
PubMed Identifier
25697851
Citation
St John Sutton M, Plappert T, Adamson PB, Li P, Christman SA, Chung ES, Curtis AB. Left Ventricular Reverse Remodeling With Biventricular Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Heart Failure in the BLOCK HF Trial. Circ Heart Fail. 2015 May;8(3):510-8. doi: 10.1161/CIRCHEARTFAILURE.114.001626. Epub 2015 Feb 19.
Results Reference
derived
PubMed Identifier
23614585
Citation
Curtis AB, Worley SJ, Adamson PB, Chung ES, Niazi I, Sherfesee L, Shinn T, Sutton MS; Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. 2013 Apr 25;368(17):1585-93. doi: 10.1056/NEJMoa1210356.
Results Reference
derived

Learn more about this trial

Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

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