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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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