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

RECRUITINGSponsored by Impulse Dynamics
Actively Recruiting
SponsorImpulse Dynamics
Started2025-11
Est. completion2030-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07209098

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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).

Conditions3

Heart DiseaseHeart Failure and Reduced Ejection FractionNYHA Class III Heart Failure

Locations1 site

Impulse Dynamics
Marlton, New Jersey, 08053
Kathy Sherwood, MBA856-642-9933ksherwood@impulsedynamics.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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