Status:
RECRUITING
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Lead Sponsor:
Impulse Dynamics
Conditions:
Heart Failure and Reduced Ejection Fraction
NYHA Class III Heart Failure
Eligibility:
All Genders
18+ years
Brief 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 hear...
Detailed Description
Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from mult...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
4200 Patients enrolled
Trial Details
Trial ID
NCT07209098
Start Date
November 1 2025
End Date
April 1 2031
Last Update
November 18 2025
Active Locations (1)
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1
Impulse Dynamics
Marlton, New Jersey, United States, 08053