Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)

Official Summary

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).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 700 participants

Interventions

• DEVICE: Personalized cardiac pacing — Personalized cardiac pacing treatment based each patient's height and baseline LVEF.

Primary Outcomes

• 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. (Follow-up duration for endpoint analysis is 12-months.)
• Primary Safety Objective: Percentage of patients with major complications related to the system or procedure. (12-months post pacemaker implant attempt.)

Secondary Outcomes

• 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. (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. (Follow-up duration for endpoint analysis is 12-months.)
• Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups. (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. (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. (Follow-up duration for endpoint analysis is 12-months.)

Trial Locations

• Banner - University Medical Center Phoenix, Phoenix, Arizona, United States
• Sutter Health Hospital, San Francisco, California, United States
• Hartford Hospital, Hartford, Connecticut, United States
• Cardiovascular Institute of Northwest Florida, Panama City, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Norton Healthcare, Louisville, Kentucky, United States
• Cardiovascular Institute of the South, Houma, Louisiana, United States
• Saint Lukes Mid America Heart Institute, Kansas City, Missouri, United States
• The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
• Mount Carmel East, Columbus, Ohio, United States
• ...and 10 more locations

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