Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
- Patients able to complete cardiopulmonary exercise (CPX) testing
- Patients expected lifespan is greater than 12 months beyond study enrollment
- Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Exclusion Criteria:
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
- Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
- Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
- Patients with a PR interval greater than 250 milliseconds
- Patients with severe chronic obstructive pulmonary disease
- Patients with high risk coronary artery disease
- Patients who are or expect to become pregnant during this study
- Patients enrolled in concurrent studies which could confound the results of this study
- Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
- Patients with infiltrative disease or restrictive cardiomyopathy
- Patients with indication for percutaneous coronary intervention (PCI) at enrollment
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fusion Pacing OFF
Fusion Pacing ON
Arm Description
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
Outcomes
Primary Outcome Measures
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Secondary Outcome Measures
Change in Minnesota Living with Heart Failure Questionnaire score.
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Change in NT-proBNP.
Full Information
NCT ID
NCT01045291
First Posted
January 8, 2010
Last Updated
May 29, 2013
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT01045291
Brief Title
Pacing for Heart Failure With Preserved Ejection Fraction
Acronym
HFpEF
Official Title
Pacing for Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 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
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.
Detailed Description
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fusion Pacing OFF
Arm Type
Active Comparator
Arm Description
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
Arm Title
Fusion Pacing ON
Arm Type
Experimental
Arm Description
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Other Intervention Name(s)
Fusion Pacing Investigational Software, Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.
Intervention Description
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Primary Outcome Measure Information:
Title
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Title
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Secondary Outcome Measure Information:
Title
Change in Minnesota Living with Heart Failure Questionnaire score.
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Title
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Title
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Title
Change in NT-proBNP.
Time Frame
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with quantitative ejection fraction (EF) of greater than 50 percent
Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
Patients greater than 18 years of age
Patients willing and able to give informed consent
Patients available for appropriate follow-up times for the length of study
Patients able to complete cardiopulmonary exercise (CPX) testing
Patients expected lifespan is greater than 12 months beyond study enrollment
Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Exclusion Criteria:
Patients who have undergone cardiac surgery 60 days prior to enrollment
Patients who have had a myocardial infarction 90 days prior to enrollment
Patients with hemodynamically significant uncorrected cardiac valvular disease
Patients with active myocarditis and amyloidosis (if documented)
Patients with a permanent pacemaker
Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
Patients with a PR interval greater than 250 milliseconds
Patients with severe chronic obstructive pulmonary disease
Patients with high risk coronary artery disease
Patients who are or expect to become pregnant during this study
Patients enrolled in concurrent studies which could confound the results of this study
Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
Patients with infiltrative disease or restrictive cardiomyopathy
Patients with indication for percutaneous coronary intervention (PCI) at enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HFpEF Trial Leader
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Aalst
Country
Belgium
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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Pacing for Heart Failure With Preserved Ejection Fraction
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