ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group). Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Hartford Hospital
Hartford, Connecticut, United States
Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP.
Cardiovascular mortality, urgent heart failure events, and ODI heart failure events will be collected as they occur. The Kansas City Cardiomyopathy Questionnaire (KCCQ); (range of score is 0 to 100), 6-minute walk test (distance in meters), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (picograms per milliliter, pg/mL) will be collected at Baseline and the 12-months visit. Treatment and control groups will be compared using a win ratio.
Time frame: Follow-up duration for endpoint analysis is 12-months.
Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.
Adverse events will be collected as they occur. Adverse events will be adjudicated for their relationship to the implant procedure and system. Severity of adverse events related to the procedure or system will be reviewed to determine if they are major complications. Major complications are defined as complications related to the system or procedure that result in one or more of the following: death, hospitalization, prolonged hospitalization by at least 48 hours, additional surgical intervention, system modification (e.g., reposition, replacement, or explant), and/or permanent loss of device function due to mechanical or electrical dysfunction of the device. The percentage of patients undergoing a pacemaker implant attempt who experience a major complication related to the system or procedure at 12 months.
Time frame: 12-months post pacemaker implant attempt.
Secondary Objective #1: Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups.
KCCQ will be collected at baseline and 12-months and the clinical summary score (CSS) will be computed with a range of 0 to 100, 100 being the best score. The change in KCCQ-CCS will be compared between the treatment and control groups.
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Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGIowa Heart Center
Des Moines, Iowa, United States
RECRUITINGCardiovascular Institute of the South
Houma, Louisiana, United States
RECRUITINGSaint Lukes Mid America Heart Institute
Kansas City, Missouri, United States
RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGMount Carmel East
Columbus, Ohio, United States
RECRUITINGLancaster General Hospital
Lancaster, Pennsylvania, United States
RECRUITINGMedical University of South Carolina (MUSC)
Charleston, South Carolina, United States
RECRUITING...and 10 more locations
Time frame: Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #2: Compare the change in NT-proBNP from baseline to 12-months between randomized groups by comparing NT-proBNP measured at baseline and 12-months.
NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups.
Time frame: Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.
AF burden (percentage of time in atrial fibrillation) is collected by the pacemaker system. AF burden will be compared between treatment and control groups.
Time frame: Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.
The 6-minute walk test will be performed at baseline and 12-months. The change in walk test distance (in meters) from baseline to 12-months will be compared between the treatment and control groups.
Time frame: Follow-up duration for endpoint analysis is 12-months.
Secondary Objective #5: Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period.
Physical activity (hours per day) is collected by the pacemaker system. The average physical activity during the 12-month follow-up period will be compared between the treatment and control group.
Time frame: Follow-up duration for endpoint analysis is 12-months.