RecruitingNot Applicable

Intracardiac Echocardiography Guided Watchman Device Implant

United States100 participantsStarted 2022-12-02

Plain-language summary

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

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: * All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial Exclusion Criteria: * Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed. * Patients receiving a concomitant ablation procedure * Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures * Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).

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

Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

Timeframe: During the procedure

Trial details

NCT IDNCT06007872

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Oussama Wazni, MD

216-444-2131 waznio@ccf.org

View on ClinicalTrials.gov More Atrial Fibrillation trials