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

Part of paid clinical trials in Marlton, New Jersey.

Sponsor
Impulse Dynamics
Study ID
NCT07209098
Status
Recruiting
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Conditions

  • Heart Failure and Reduced Ejection Fraction
  • NYHA Class III Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 18, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
4,200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Impulse DynamicsMarltonNew Jersey08053
Kathy Sherwood, MBA
[email protected]
856-642-9933

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Impulse Dynamics· Marlton, NJ

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