Clinical Trial

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure

Study acronym: BRIGHTEN-HF
Recruiting
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Summary
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-30; most recent amendment 2026-03-23.
Status change: Not Yet Recruiting → Recruiting 2025-11-14
Trial Details
NCT Number NCT07209098
Lead Sponsor Impulse Dynamics
Conditions Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure
Enrollment 4,200 participants
Start Date 2025-11-18
Primary Completion 2030-10 (estimated)
Study Completion 2031-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-24