Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Recruiting
Observational Study
Heart Failure and Reduced Ejection Fraction
NYHA Class III Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 4,200 (estimated)
- Sponsor
- Impulse Dynamics · Industry
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About This Trial
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 Locations
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Eligibility 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 mo…
Contacts