Active — Not RecruitingNot Applicable

CLIP-IT Post-Market Study

United States198 participantsStarted 2024-02-26

Plain-language summary

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

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: * Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System * Greater than or equal to 18 years of age * The subject is willing and able to provide written informed consent and comply with study visit requirements Exclusion Criteria: * Prior left atrial appendage (LAA) isolation attempt(s) * Need for emergent cardiac surgery * Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE) * Life expectancy of less than 12 months * History of cardiac surgery * Pericarditis * Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure * Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest * Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment * Ejection fraction less than 30% * Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) \<30 ml/min) * New York Heart Association (NYHA) Class IV heart failure symptoms * Patient has a documented history of substance (drug or alcohol) abuse * Known allergy to device components (Nickel and/or Titanium) * In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outw…

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

Rate of successful exclusion of the left atrial appendage (LAA) from the heart

Timeframe: 3 months post procedure

Rate of device related adverse events

Timeframe: 30 days post procedure

Trial details

NCT IDNCT06203054

SponsorMedtronic Cardiac Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-26

View on ClinicalTrials.gov More Left Atrial Appendage Exclusion 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.