Actively Recruiting
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Led by Impulse Dynamics · Updated on 2026-03-24
4200
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
- Continuous representation in the database in the year prior to index.
- Age 18 or older will be enrolled in either the treatment or control arm of the study.
- NYHA III heart failure,
- Not receiving CRT
- EF 25 - 45%, inclusive.
- 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
- Subject has had a prior heart transplant
- Subject with mechanical tricuspid valve.
- Subject has a left ventricular assist device (LVAD).
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Impulse Dynamics
Marlton, New Jersey, United States, 08053
Actively Recruiting
Research Team
K
Kathy Sherwood, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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