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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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).

Study sites (1)

NJ