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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)

Who can join

Ages 18 and older · All sexes

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).

About the study

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.

What is being tested

• Cardiac Contractility Modulation (CCM) (device)

Sponsor: Impulse Dynamics · Participants: 4,200 · Started: Nov 18, 2025

Contact the study team

• Kathy Sherwood, MBA · Phone: 856-642-9933

Official record on ClinicalTrials.gov — NCT07209098

Locations in the U.S.

Conditions

• Systolic Heart Failure
• Heart Failure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.