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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5500 (estimated) |
| Sponsor | Impulse Dynamics Industry-sponsored |
| Locations | 30 sites (Mesa, Arizona and 29 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | August 15, 2035 |
| Study ends | August 1, 2036 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07112924 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
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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
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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
- Study coordinator: Karl Van Wygerden
- Email: kvanwygerden@impulsedynamics.com
- Phone: 856-642-9933
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.