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

Study acronym: BRIGHTEN-HF
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Nov 2025 to Nov 18, 2025v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Oct 2025 to Nov 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Oct 2025 to Nov 2025
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov