Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure
Conditions
Keywords
Heart failure, Reduced ejection fraction, Cardiac Contractility Modulation, CCM, NYHA III, Propensity Score Matching, All-Cause Mortality, Heart Failure Hospitalizations, CED
Brief summary
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
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.
Sponsors
Impulse Dynamics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first heart failure hospitalization or all-cause death | 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. | Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States. |
Countries
United States
Contacts
CONTACTKathy Sherwood, MBA
Outcome results
None listed