Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Contractility Modulation (CCM).
- Who it may be relevant to
- Registry conditions: Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
Overview
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.
Detailed description
Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from multiple U.S. healthcare systems. 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.
Interventions
- Device Cardiac Contractility Modulation (CCM)
CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
Primary outcome measures
- Time to first heart failure hospitalization or all-cause death [Time frame: Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Subject has had a prior heart transplant
- Subject with mechanical tricuspid valve.
- Subject has a left ventricular assist device (LVAD).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Impulse Dynamics — Marlton
Identifiers
NCT: NCT07209098 · CA_CP_2558