Comparing cardiac contractility modulation (CCM) to usual care for people with reduced ejection fraction and NYHA class III heart failure
Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
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 |
|---|---|
| Enrollment | 4200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Impulse Dynamics Industry-sponsored |
| Locations | 1 site (Marlton, New Jersey) |
| Trial ID | NCT07209098 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marlton, New Jersey
- Impulse Dynamics — Marlton, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Kathy Sherwood, MBA
- Email: ksherwood@impulsedynamics.com
- Phone: 856-642-9933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.