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Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Summary
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2024-09-11
Completion Date
2027-07
Last Updated
2026-01-27
Healthy Volunteers
No
Interventions
Pacemaker PLR + TRT ON
RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON
Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
RAMware modified implantable pulse generator (IPG)
Locations (9)
NCH Heart Institute
Naples, Florida, United States
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois, United States
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Duke University
Durham, North Carolina, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Dallas VA Medical Center
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States