Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion (NCT06348394) | Clinical Trial Compass
RecruitingNot Applicable
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
United States444 participantsStarted 2025-02-25
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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 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.
What they're measuring
1
Procedural success following implantation of the left atrial appendage occlusion (LAAO) device.
✕. 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