Propensity-Matched Study of Cardiac Contractility Modulation Therapy in 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)

NCT07209098•Impulse Dynamics

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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.

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 multiple U.S. healthcare systems. The database includes demographics, clinical notes, imaging, laboratory results, medications, social determinants of health, and other relevant healthcare information, with up to 8 years of historical clinical data updated regularly.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Impulse Dynamics

Marlton, New Jersey, United States

Key Dates

Start Date

November 1, 2025

Primary Completion Date

October 1, 2030

Completion Date

April 1, 2031

Last Updated

November 18, 2025

Enrollment

4,200

ESTIMATED participants

Conditions

Heart Failure and Reduced Ejection FractionNYHA Class III Heart Failure

Interventions

Cardiac Contractility Modulation (CCM)

DEVICE

Contacts

Kathy Sherwood, MBA

CONTACT

856-642-9933 ksherwood@impulsedynamics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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