ClinicalTrials.gov record NCT07112924

CCM OPEN HF Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a single-arm, observational registry collecting real-world data on patients who have received or will receive Cardiac Contractility Modulation (CCM) therapy with an Impulse Dynamics system. The study includes both retrospective and prospective participants and follows them for at least 5 years. It aims to track hospitalizations, device- or procedure-related complications, clinical outcomes, and device performance.

What it is studying. The registry is collecting long-term safety and outcome data for CCM therapy in routine clinical practice. It will measure heart-failure hospitalizations and length of stay, device- and procedure-related complications over time, mortality, functional status, heart structure and function, laboratory measures (e.g., BNP, kidney function), device dosing and battery charging compliance, and outcomes in pre-specified subgroups.

What the researchers hope to learn. To describe long-term safety of CCM therapy and its association with heart-failure hospitalizations, mortality, functional status, cardiac remodeling, device-related events, dose-response and device charging behavior in a real-world population.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a global, prospective and retrospective, multicenter, single-arm, observational study intended to include patients who will receive/have received CCM therapy with an Impulse Dynamics system, including future CCM technologies (e.g. CCM-D), for a follow-up period of at least 5 years.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have their medical and device data collected and followed for at least 5 years. This includes review of medical records for hospitalizations and procedures, device checks and charging/compliance data, questionnaires such as the Kansas City Cardiomyopathy Questionnaire, assessments of functional status (NYHA class, 6-minute walk), and routine clinical tests or imaging (for example, measures of heart function and blood markers) at baseline and repeated timepoints up to 5 years. Retrospective enrollees will provide past medical and device data (including the year before implantation where available). The study is observational and collects outcomes and device-related complications rather than assigning new treatments.

How the study is structured. A multicenter, single-arm observational study that enrolls people retrospectively and prospectively who have received or will receive an Impulse Dynamics CCM device. Participants are followed for at least 5 years. Data come from medical records, device data and routine clinical assessments (examples in the registry include hospitalizations, survival, questionnaires like the KCCQ, 6-minute walk test, heart imaging measures, and blood tests). There is no randomized comparison or assignment to a new treatment by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Heart Failure. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Nov 1, 2025
Primary completion
Aug 15, 2035 (estimated)
Study completion
Aug 1, 2036 (estimated)
Target enrollment
5500 participants (estimated)
Last updated on registry
Apr 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Impulse Dynamics

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (28)

Terms used on this page · explanations by MedicalUpdates.ai

registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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