Recruiting

Cardiac Contractility Modulation

Sponsor:

Impulse Dynamics

Code:

NCT07209098

Conditions

Heart Failure and Reduced Ejection Fraction

NYHA Class III Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Contractility Modulation (CCM)

Study Details

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.

Conditions

Heart Failure and Reduced Ejection Fraction

NYHA Class III Heart Failure

Study ID

NCT07209098

Start date

Nov 18, 2025

Status verified date

Nov, 2025

Completion date

Apr, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4200 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

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.

Control Group

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.

Interventions

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Kathy Sherwood, MBA

856-642-9933ksherwood@impulsedynamics.com

Locations

Impulse Dynamics

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Kathy Sherwood, MBA

856-642-9933ksherwood@impulsedynamics.com

More Information

Sponsor

Impulse Dynamics

Last update posted

Mar 24, 2026

Last verified

Nov, 2025

Keywords

  • Heart failure
  • Reduced ejection fraction
  • Cardiac Contractility Modulation
  • CCM
  • NYHA III
  • Propensity Score Matching
  • All-Cause Mortality
  • Heart Failure Hospitalizations
  • CED

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Impulse Dynamics on 2026-03-24.