Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImpulse Dynamics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subject has had a prior heart transplant
Subject with mechanical tricuspid valve.
Subject has a left ventricular assist device (LVAD).
Trial design
Treatments tested in this trial
- Cardiac Contractility Modulation (CCM)
Treatment groups
4,200 Participants
are divided into 2 treatment groupsLocations
1Impulse Dynamics08053, MarltonNew Jersey, United States
Sponsors and collaborators
Impulse Dynamics
Lead sponsor
Source ClinicalTrials.gov