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NCT Number: NCT07209098

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure

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.

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Key information

Conditions

Heart Failure and Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic NYHA Class III Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Impulse Dynamics

Marlton, New Jersey, 08053, United States

Location status: Recruiting

Location contact

Kathy Sherwood, MBA

CONTACT

[email protected]

856-642-9933

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cardiac Contractility Modulation (CCM)

Device

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 outcomes

  1. 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.

    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.

Other outcomes

  1. Time to recurrent heart failure hospitalization

    Time frame: Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.

    Time from index date (CCM implantation for treatment patients) to each heart failure-related hospitalization, including first and subsequent hospitalizations, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.

  2. Time to all-cause mortality

    Time frame: Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.

    Time from index date (CCM implantation for treatment patients) to death from any cause, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Sherwood, MBA

CONTACT

[email protected]

856-642-9933

Sponsors and collaborators

Lead sponsor

Impulse Dynamics

Industry

Registry information

Official study title

Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)

Acronym: BRIGHTEN-HF

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Oct 6, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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