NCT07209098

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,200

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Nov 2025Apr 2031

First Submitted

Initial submission to the registry

September 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

March 24, 2026

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

September 30, 2025

Last Update Submit

March 23, 2026

Conditions

Heart Failure and Reduced Ejection FractionNYHA Class III Heart Failure

Keywords

Heart failureReduced ejection fractionCardiac Contractility ModulationCCMNYHA IIIPropensity Score MatchingAll-Cause MortalityHeart Failure HospitalizationsCED

Outcome Measures

Primary Outcomes (1)

  • Time to first heart failure hospitalization or all-cause death

    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.

    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.

Other Outcomes (2)

  • Time to recurrent heart failure hospitalization

    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 to all-cause mortality

    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.

Study Arms (2)

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.

Device: Cardiac Contractility Modulation (CCM)

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)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.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are patients with heart failure who are identified from a large, de-identified, multi-system electronic health record (EHR) database representing diverse healthcare settings across the United States. The database includes patients receiving care in hospitals, outpatient clinics, and other sites where cardiac contractility modulation (CCM) therapy is delivered. The population reflects typical sites of CCM implantation in Medicare-eligible adults across multiple states and integrated delivery networks (IDNs).

You may qualify if:

  • 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.

You may not qualify if:

  • Subject has had a prior heart transplant
  • Subject with mechanical tricuspid valve.
  • Subject has a left ventricular assist device (LVAD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Impulse Dynamics

Marlton, New Jersey, 08053, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Kathy Sherwood, MBA

CONTACT

856-642-9933ksherwood@impulsedynamics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 6, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

March 24, 2026

Record last verified: 2025-11

Locations

US(1)