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

Recruiting now

Conditions studied: Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure

In brief

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.

Key facts

Study ID

NCT07209098

Run by

Impulse Dynamics

People needed

4200

Starts

2025-11-18

Expected to finish

2031-04-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject has had a prior heart transplant
• Subject with mechanical tricuspid valve.
• Subject has a left ventricular assist device (LVAD).

Where it is running

• Impulse Dynamics — Marlton, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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