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Studies a device therapy for heart failure in patients with reduced heart pumping

Follows people with heart failure treated with a device that strengthens heart contractions.

Plain-language title generated from the registry record
Registry title: Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure

Key facts

Where
Marlton, United StatesSee the site

Where in United States

  • Impulse DynamicsMarlton, United StatesTaking people

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Trial details

Who runs it
Impulse Dynamics
Trial code
NCT07209098
Record updated
24 March 2026
Original description
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.Read full original descriptionShow less

Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)

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.

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

ClinicalTrials.gov NCT07209098