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Recruiting NCT06348394

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Trial Parameters

Condition Left Atrial Appendage Closure
Sponsor Baylor Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 444
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2025-02-25
Completion 2026-12-14
Interventions
Intracardiac Echocardiography

Brief 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 Criteria

Inclusion Criteria: 1. Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF. 2. Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3. 3. Patient suitable for OAC with warfarin or DOAC and have appropriate rationale to seek a nonpharmacologic alternative to long-term OAC, meeting commercial LAAO criteria indications. 4. Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE). 5. Patient should be able to comply with the protocol. 6. Provide written informed consent before study participation. 7. Ages 18 and above Exclusion Criteria 1\) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria: 1. Presence of an intracardiac thrombus on the preprocedural TEE or CT. 2. History of previously implanted device for atrial septal defect or patent foramen ovale.

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