Comparing cardiac contractility modulation (CCM) to usual care for people with reduced ejection fraction and NYHA class III heart failure
Official title: Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
Run by Impulse Dynamics · NCT07209098 · Data updated 2026-11-12
This study tests whether cardiac contractility modulation (CCM) reduces deaths and heart failure hospital stays in Medicare‑eligible adults with NYHA class III heart failure and an ejection fraction of 25–45%.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4200 (estimated) |
| Sponsor | Impulse Dynamics Industry-sponsored |
| Locations | 1 site (Marlton, New Jersey) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | October 2030 |
| Study ends | April 2031 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07209098 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with NYHA class III heart failure, an ejection fraction between 25% and 45%, who remain symptomatic after at least three months of optimized guideline‑directed medical therapy, are not receiving CRT, and do not have prior heart transplant, LVAD, or a mechanical tricuspid valve.
✕Probably not a fit
Patients with prior heart transplant, an LVAD, a mechanical tricuspid valve, those already receiving cardiac resynchronization therapy, or those who do not meet the EF or symptom requirements are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicenter, propensity‑matched coverage‑with‑evidence development analysis compares outcomes for patients who receive CCM with a matched control group drawn from a large, de‑identified U.S. electronic health record (EHR) database. The database includes up to eight years of clinical history from multiple healthcare systems, covering demographics, notes, imaging, labs, medications, and social determinants of health. Treatment and control groups are matched on clinical characteristics to reduce confounding in this observational design rather than by random assignment. Primary outcomes include mortality and heart failure hospitalizations in Medicare‑eligible patients meeting indications for CCM.
Why it matters
Potential benefit: If successful, CCM could reduce heart failure hospitalizations and deaths for eligible patients, improving survival and quality of life.
How similar studies have gone: Previous randomized and registry studies of CCM have shown improvements in symptoms, exercise capacity, and quality of life, but evidence for reductions in mortality and hospitalizations is limited, motivating this propensity‑matched analysis.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Impulse Dynamics
Marlton, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Kathy Sherwood, MBA
- Email: ksherwood@impulsedynamics.com
- Phone: 856-642-9933
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.