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Long-term registry of CCM therapy for heart failure

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

Observational Impulse Dynamics · NCT07112924

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
Enrollment5500 (estimated)
Ages18 Years and up
SexAll
SponsorImpulse Dynamics Industry-sponsored
Locations28 sites (Mesa, Arizona and 27 other locations)
Trial IDNCT07112924 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Mesa, Arizona and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureCCMOptimizerImplantable Pulse GeneratorFDA ApprovedHeart Failure HospitalizationIschemic vs non-ischemicCRT non-responders
Last reviewed 2026-06-13 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.