NCT06348394

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices. Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler. Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.

Conditions

• Left Atrial Appendage Closure

Interventions

Type	Name	Description
OTHER	Intracardiac Echocardiography	Transesophageal echocardiography will be performed under general anesthesia.

Timeline

• Start date: 2025-02-25
• Primary completion: 2026-12-14
• Completion: 2026-12-30
• First posted: 2024-04-04
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study