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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)

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

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

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

Arm Title

Fusion Pacing ON

Arm Type

Experimental

Arm Description

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