RecruitingNot ApplicableNCT06348394

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion


Sponsor

Baylor Research Institute

Enrollment

444 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two imaging methods used to guide a procedure that closes off a small pouch in the heart (left atrial appendage) where blood clots can form in people with irregular heartbeats (atrial fibrillation). One method uses a probe placed in the esophagus (transesophageal), and the other uses a tiny camera inserted directly into the heart (intracardiac). The device closure is an alternative for people who cannot take blood thinners long-term. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-valvular atrial fibrillation (an irregular heart rhythm not caused by a faulty heart valve) - You are at high risk for stroke (CHADS2 score of 2 or higher, or CHA2DS2-VASc score of 3 or higher) - You have a medical reason to avoid long-term blood thinners and are a suitable candidate for the closure device **You may NOT be eligible if...** - You have a blood clot already present in the left atrial appendage - You cannot safely undergo either imaging method - You have active infection or a condition making this procedure too risky 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

OTHERIntracardiac Echocardiography

Transesophageal echocardiography will be performed under general anesthesia.


Locations(1)

Baylor Scott and White Heart Hospital

Plano, Texas, United States

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NCT06348394


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