The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.
Prospective, Randomized (3:2 active:control), Open Label, Event-driven Interventional Study. All subjects undergo the following: Baseline, Randomization, (Implantation \& Optimization for subjects randomized to the active therapy), and Follow-up Period, followed by an Extension period, which lasts until the end of the study. The Clinical Events Committee (CEC) and Data Monitoring and Safety Board (DSMB) will conduct scheduled independent reviews of the data at the following time-points in order to ensure that an ongoing acceptable safety profile is being achieved.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
730
Vagal nerve stimulation with the CardioFit® system
Usual care for LV dysfunction and heart failure (no CardioFit System implant)
Number of participants reaching all-cause mortality or unplanned heart failure hospitalization or equivalent.
The primary efficacy end-point of the study is the composite of all-cause mortality or unplanned heart failure hospitalization equivalent using a time to first event analysis, as compared between the two study arms after a pre-specified number of such events have been accumulated.
Time frame: Until the end of the study
Co-Primary Safety Endpoints: a) Freedom from procedure and system related complication events and b) Number of all-cause death cases or complications resulting in hospitalization
The co-primary safety endpoints of the study are the following: 1. Freedom from procedure and system related complication events through 90 days 2. Demonstrate time to first event equivalence in all-cause mortality and complications resulting in prolonged hospitalization between the Control and CardioFit
Time frame: a) 90 days and b) Until the end of the study
The rate of unplanned heart failure hospitalization equivalents
The rate of unplanned heart failure hospitalization equivalents
Time frame: Until the end of the study
Mean improvement in LVESVi from baseline to 12-months
Mean improvement in LVESVi from baseline to 12-months
Time frame: 12 Months
Mean improvement in the summary score of the KCCQ from baseline to 12-months
Mean improvement in the summary score of the KCCQ from baseline to 12-months
Time frame: 12 Months
Mean improvement in 6 minute walk test from baseline to 12-months
Mean improvement in 6 minute walk test from baseline to 12-months
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University of Alabama Birmingham
Birmingham, Alabama, United States
Banner Research Institute
Mesa, Arizona, United States
Glendale Memorial Hospital
Glendale, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Chula Vista Heart Clinic
San Diego, California, United States
South Denver Cardiology
Denver, Colorado, United States
Clearwater Cardiovascular Consultants/Morton Plant
Clearwater, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Hospital, CV Research Institute
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
...and 77 more locations
Time frame: 12 Months
All cause mortality and the number of unplanned heart failure hospitalization equivalents
All cause mortality and the number of unplanned heart failure hospitalization equivalents
Time frame: Until the end of the study
Rate of hospitalization-free days
Rate of hospitalization-free days
Time frame: Until the end of the study
Secondary Safety Endpoints: Mortality and Complications
The following additional (secondary) safety endpoint data will also be evaluated comparatively at 6- and 12-months: 1. All-cause mortality 2. Cardiovascular mortality 3. Serious adverse events 4. Complications 5. System- or procedure-related complications
Time frame: Until the end of the study