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

Left Atrial Appendage Closure

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

Inclusion Criteria7

Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥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.
Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
Patient should be able to comply with the protocol.
Provide written informed consent before study participation.
Ages 18 and above

Exclusion Criteria10

\) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
Presence of an intracardiac thrombus on the preprocedural TEE or CT.
History of previously implanted device for atrial septal defect or patent foramen ovale.
Severe LV dysfunction (LVEF \< 40%) or greater than moderate valvular heart disease.
Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
For women of childbearing potential: Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure
Children below 18 years, prisoners and patients who are unable to provide consent are excluded.