New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
Device will be programmed to normal lower rates
University of Arizona - Sarver Heart Center
Tucson, Arizona, United States
St Joseph's Medical Center
Stockton, California, United States
Northwestern University
Chicago, Illinois, United States
Number of Participants Who Remained on Study
REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.
Time frame: Baseline through 12 week follow-up
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University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
The Lindner Research Center
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States