Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBaylor Research Institute

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intracardiac Echocardiography

Treatment groups

444 Participants
are divided into 2 treatment groups

Sponsors and collaborators