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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fusion Pacing OFF | Active Comparator | 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. |
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| Fusion Pacing ON | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy-Defibrillator (CRT-D) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events while the Fusion Pacing download is active vs. inactive. | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit | |
| Percentage of time the Fusion Pacing is active throughout a four-month follow-up period. | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Minnesota Living with Heart Failure Questionnaire score. | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit | |
| Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX). | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HFpEF Trial Leader | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
| National Taiwan University Hospital |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in echocardiography measures: E/E', Ejection Fraction, LV EDV. | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit |
| Change in NT-proBNP. | From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit |
| Taipei |
| Taiwan |