Clinical trial Recruiting at 10 sites Observational Ages 18 and up

Long-term registry of CCM therapy for heart failure

Official title: CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure

Run by Impulse Dynamics · NCT07112924 · Data updated 2026-11-12

This registry will see if cardiac contractility modulation (CCM) devices are safe and help people with heart failure over at least five years in routine care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment5500 (estimated)
SponsorImpulse Dynamics
Industry-sponsored
Locations30 sites (Mesa, Arizona and 29 other locations)
StatusRecruiting
StartedNovember 1, 2025
Main results expectedAugust 15, 2035
Study endsAugust 1, 2036
Registry record updatedOctober 27, 2026
Trial IDNCT07112924 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with heart failure who have already received or are planned to receive an Impulse Dynamics CCM device and who can provide informed consent and attend follow-up visits.

Probably not a fit

Patients with a mechanical tricuspid valve or those unable or unwilling to comply with follow-up are unlikely to be included or to gain benefit from this registry's findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global, multicenter, single-arm observational registry that will enroll patients who have received or will receive an Impulse Dynamics CCM system, including future CCM-D devices. The registry includes both prospective and retrospective patient data and plans at least five years of follow-up per patient. Data collected will focus on long-term safety, device performance, symptoms, hospitalization, and functional outcomes in a real-world setting. Participating sites currently include several centers in Arizona with expansion to other centers expected.

Why it matters

Potential benefit: If successful, the registry could confirm long-term safety and sustained symptom and functional benefits of CCM therapy in routine clinical practice.

How similar studies have gone: Previous randomized and observational studies and regulatory approval for CCM in selected heart failure populations have shown symptomatic and functional improvements, but long-term real-world evidence is still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who have /will be implanted with Impulse Dynamics CCM technologies (e.g. CCM or CCM-D when available) as determined by investigators
* Willing and able to provide informed consent, including for use of data for research purposes (e.g. publication, sub-studies/sub-analyses)

Exclusion Criteria:

* Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
* Subjects with a mechanical tricuspid valve

Where it's running

  • Cardiovascular Associates of Mesa
    Mesa, Arizona, United States
    Recruiting
  • Peak Heart and Vascular
    Surprise, Arizona, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Cardiovascular Specialists of New England Research Foundation
    Londonderry, New Hampshire, United States
    Recruiting
  • Heart House
    Haddon Heights, New Jersey, United States
    Recruiting
  • Oklahoma Heart Hospital Research Foundation
    Oklahoma City, Oklahoma, United States
    Recruiting
Show 24 more locations
  • The Stern Cardiovascular Foundation, Inc
    Germantown, Tennessee, United States
    Recruiting
  • David Turbay, MD
    El Paso, Texas, United States
    Recruiting
  • CHRISTUS Trinity Mother Frances Health System
    Tyler, Texas, United States
    Recruiting
  • Centra Health, Inc. dba Stroobants Cardiovascular Center
    Lynchburg, Virginia, United States
    Recruiting
  • University of Arizona and Banner University Medical Center Phoenix
    Phoenix, Arizona, United States
    Not yet recruiting
  • HonorHealth Research Institute
    Phoenix, Arizona, United States
    Not yet recruiting
  • AdventHealth Orlando
    Orlando, Florida, United States
    Not yet recruiting
  • AdventHealth Tampa
    Tampa, Florida, United States
    Not yet recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas, United States
    Not yet recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Not yet recruiting
  • Henry Ford Providence Hospital
    Novi, Michigan, United States
    Not yet recruiting
  • Trinity Ann Arbor d/b/a Michigan Heart Ann Arbor
    Ypsilanti, Michigan, United States
    Not yet recruiting
  • Minneapolis Heart Institute Research Foundation
    Minneapolis, Minnesota, United States
    Not yet recruiting
  • Saint Luke's Hospital Mid America Heart Institute
    Kansas City, Missouri, United States
    Not yet recruiting
  • Saint Luke's Hospital of Kansas City
    Kansas City, Missouri, United States
    Not yet recruiting
  • Deborah Heart and Lung Center
    Browns Mills, New Jersey, United States
    Not yet recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Not yet recruiting
  • Rutgers New Jersey Medical School & University Hospital
    Newark, New Jersey, United States
    Not yet recruiting
  • Providence St. Vincent Medical Center
    Portland, Oregon, United States
    Not yet recruiting
  • Legacy Medical Group Cardiology
    Portland, Oregon, United States
    Not yet recruiting
  • Reading Hospital
    West Reading, Pennsylvania, United States
    Not yet recruiting
  • Texan Cardiovascular Institute
    El Paso, Texas, United States
    Not yet recruiting
  • PeaceHealth Southwest Medical Center
    Vancouver, Washington, United States
    Not yet recruiting
  • Advocate Aurora Health-St. Lukes
    Milwaukee, Wisconsin, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.