RecruitingNot ApplicableNCT06007872

Intracardiac Echocardiography Guided Watchman Device Implant

Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant


Sponsor

The Cleveland Clinic

Enrollment

100 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two guidance techniques for implanting a Watchman device — a small plug used to close off part of the heart (the left atrial appendage) in people with atrial fibrillation (AFib) to reduce stroke risk. One method uses a camera inside the heart (intracardiac echocardiography), while the usual method uses a camera down the throat (transesophageal echocardiography). **You may be eligible if:** - You meet standard clinical guidelines for receiving a Watchman device - You are not already enrolled in another active clinical trial **You may NOT be eligible if:** - A camera down the throat (TEE) cannot be performed and a heart camera (ICE) only approach is needed - You are having an additional ablation procedure at the same time - You have had a prior incomplete procedure to close off the left atrial appendage - Your anatomy makes the procedure technically difficult (e.g., you have a PFO or ASD closure device in place) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntracardiac Echocardiography (ICE)

ICE will be used to guide trans-septal puncture and to guide device implant.


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT06007872


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