Recruiting

LAAC vs. TEE

Sponsor:

Baylor Research Institute

Code:

NCT06348394

Conditions

Left Atrial Appendage Closure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intracardiac Echocardiography

Traditional transesophageal echocardiography

Study Details

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.

Conditions

Left Atrial Appendage Closure

Study ID

NCT06348394

Start date

Feb 25, 2025

Status verified date

Sep, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.
3. Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
4. Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
6. Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
7. 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.
8. 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
9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.

Study Design

Enrollment

444 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Intracardiac echocardiography Left atrial appendage closure.

Intra cardiac echocardiography will be performed prior to left atrial appendage closure.

placebo comparator: Traditional transesophageal echocardiography guided Left atrial appendage closure

Transesophageal Echocardiography will be performed under general anesthesia.

Interventions

Intracardiac Echocardiography

Transesophageal echocardiography will be performed under general anesthesia.

Traditional transesophageal echocardiography

Traditional transesophageal echocardiography guided Left atrial appendage closure

Primary outcome measure

  • Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. [ Time Frame: Intra op ]

Central Contacts and Locations

Central contacts

Locations

Baylor Scott and White Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Principal Investigator:

Karim Al-Azizi, MD

More Information

Sponsor

Baylor Research Institute

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-09-03.