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RECRUITING
NCT05839730
NA

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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

DEVICE

Pacemaker PLR + TRT ON

RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON

DEVICE

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