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

Recruitingn/aAges 18 Years - anyAllImpulse Dynamics
NCT07209098 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Continuous representation in the database in the year prior to index. 2. Age 18 or older will be enrolled in either the treatment or control arm of the study. 3. NYHA III heart failure, 4. Not receiving CRT 5. EF 25 - 45%, inclusive. 6. Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation. Exclusion Criteria 1. Subject has had a prior heart transplant 2. Subject with mechanical tricuspid valve. 3. Subject has a left ventricular assist device (LVAD).
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What it tests

  • Cardiac Contractility Modulation (CCM)
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Where

1 site
Impulse Dynamics
Marlton, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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