Intracardiac versus transesophageal guidance for left atrial appendage closure

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

This trial will test whether using intracardiac echocardiography (ICE) instead of transesophageal echocardiography (TEE) to guide left atrial appendage closure is safe and works well for people with non-valvular atrial fibrillation who want a non-drug option to reduce stroke risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 444 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Baylor Research Institute (Academic / other)
• Locations: 1 site (Plano, Texas)
• Trial ID: NCT06348394 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective, randomized comparison of ICE-guided versus TEE-guided percutaneous left atrial appendage occlusion (LAAO). Participants have non-valvular atrial fibrillation and are at elevated stroke risk and are suitable candidates for commercial LAAO devices. The primary endpoint is procedural success defined by correct device position without device-related complications and no peri-device leak >5 mm; secondary endpoints include periprocedural complications, procedural metrics, hospital cost and patient satisfaction, and clinical status at 45 days. Procedures, imaging protocols, and follow-up are standardized and outcomes are collected in-hospital and at a 45-day visit.

Who should consider this trial

Good fit: Adults (≥18 years) with non-valvular atrial fibrillation at high stroke risk (CHADS2 ≥2 or CHA2DS2-VASc ≥3), suitable for oral anticoagulation but seeking a nonpharmacologic LAAO option, able to undergo preprocedural CT or TEE and provide informed consent.

Not a fit: Patients with an intracardiac thrombus on preprocedural imaging, a history of prior septal occluder devices, or other contraindications to percutaneous LAAO are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, ICE guidance could allow effective LAAO with less need for general anesthesia and TEE, improving patient comfort and potentially shortening procedure time and hospital cost.

How similar studies have performed: Prior registries and nonrandomized series have suggested ICE can guide LAAO safely and may reduce anesthesia needs, but randomized data are limited.

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.
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.

Where this trial is running

Plano, Texas

• Baylor Scott and White Heart Hospital — Plano, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Bonnie Ostergren

Conditions Left Atrial Appendage Closure