RecruitingNot Applicable

CCM OPEN HF Registry

United States5,500 participantsStarted 2025-11-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations

Timeframe: 1 Year

Demonstrate the long-term safety of CCM therapy in a real-world setting, by assessing the rate of device- or procedure-related complications.

Timeframe: 5 Years

Trial details

NCT IDNCT07112924

SponsorImpulse Dynamics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-08-15

Contact for this trial

Karl Van Wygerden

856-642-9933 kvanwygerden@impulsedynamics.com

View on ClinicalTrials.gov More Heart Failure trials