Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure (BRIGHTEN-HF)

Impulse Dynamics

Status: Enrolling

Conditions: NYHA Class III Heart Failure; Heart Failure and Reduced Ejection Fraction

Treatments: Device: Cardiac Contractility Modulation (CCM)

Study type: Observational

Funder types: Industry

Identifiers

NCT07209098

CA_CP_2558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

4,200 participants in 2 patient groups

Treatment Group

Description:

Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System.

Treatment:

Device: Cardiac Contractility Modulation (CCM)

Control Group

Description:

The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant.