Dual Site Left Ventricular (LV) Pacing (DIVA)
Primary Purpose
Congestive Heart Failure, LV Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual Site LV Pacing
BiV Pacing
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
- On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
- A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
- Left ventricular ejection fraction (LVEF) < 35% or equal
- Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
- Have a life expectancy of more than 180 days, per physician discretion
- Age 40 or above, ensuring of legal age to give informed consent specific to state and national law
Exclusion Criteria:
- Have had previous cardiac resynchronization therapy or a previous coronary venous lead
- Unable to perform a Six-Minute Hall Walk (6MHW) Test
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
- Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- Have a mechanical tricuspid prosthesis
- Has severe aortic or mitral stenosis
- Enrolled in any concurrent study that may confound the results of this study
- Patients who are or suspect they may be pregnant or plan to become pregnant
Sites / Locations
- Aurora Cardiovascular Services
- Aurora Cardiovascular Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dual Site LV Pacing
BiV Pacing
Arm Description
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Outcomes
Primary Outcome Measures
Change in Left Ventricular End Systolic Volume (LVESV)
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
Secondary Outcome Measures
Full Information
NCT ID
NCT00944125
First Posted
July 17, 2009
Last Updated
March 2, 2016
Sponsor
Imran Niazi
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00944125
Brief Title
Dual Site Left Ventricular (LV) Pacing
Acronym
DIVA
Official Title
Dual Site LV Pacing Study: Prospective Randomized Blinded Crossover Study of Patients Meeting Current CRT-D Indication to be Implanted With Dual LV Pacing Leads and Paced Chronically for at Least 6 Months Post-implant.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
for administrative reasons (no safety concerns), no analysis completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Imran Niazi
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:
Improves the way the heart's left ventricle functions
Decreases the number of hospital and clinic visits for heart failure related symptoms
Slows the rate patients experience certain heart failure symptoms
Reduces uncoordinated heart contractions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, LV Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual Site LV Pacing
Arm Type
Active Comparator
Arm Description
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Arm Title
BiV Pacing
Arm Type
Active Comparator
Arm Description
Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Intervention Type
Device
Intervention Name(s)
Dual Site LV Pacing
Intervention Description
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Intervention Type
Device
Intervention Name(s)
BiV Pacing
Intervention Description
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Systolic Volume (LVESV)
Description
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
Time Frame
At 6 months to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
Left ventricular ejection fraction (LVEF) < 35% or equal
Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
Have a life expectancy of more than 180 days, per physician discretion
Age 40 or above, ensuring of legal age to give informed consent specific to state and national law
Exclusion Criteria:
Have had previous cardiac resynchronization therapy or a previous coronary venous lead
Unable to perform a Six-Minute Hall Walk (6MHW) Test
Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Have a mechanical tricuspid prosthesis
Has severe aortic or mitral stenosis
Enrolled in any concurrent study that may confound the results of this study
Patients who are or suspect they may be pregnant or plan to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran K Niazi, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Cardiovascular Services
City
Lake Geneva
State/Province
Wisconsin
ZIP/Postal Code
53147
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dual Site Left Ventricular (LV) Pacing
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