NCT06969118

RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

A Multi-center, Randomized, Controlled Study Comparing Minimalist Procedure With Standard Procedure for Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous left atrial appendage closure (LAAC) is an effective strategy for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Standard procedure requires general anesthesia, transesophageal echocardiography (TEE) guidance. With the experience accumulation, LAAC can be successfully completed in many centers under local anesthesia, the guidance of X-ray and transthoracic echocardiography (TTE), also known as minimalist procedure. Our center was one of the earliest to carry out minimalist procedure worldwide. At present, expert consensus suggests that minimalist procedure is feasible in experienced centers, but the relevant evidence is insufficient. Some single-arm studies have shown that minimalist procedure is safe and effective. However, there is currently a lack of direct evidence to compare the strengths and weaknesses of these two LAAC procedures. The goal of the study was to compare the effectiveness and safety of minimalist procedure and standard procedure for LAAC in patients with NVAF.

Detailed description

This is a prospective, randomized, controlled, multi-center clinical study designed to compare the safety and efficacy of minimalism transcatheter LAAC versus standard transcatheter LAAC in NVAF patients. The study aims to enroll approximately 200 NVAF patients requiring transcatheter LAAC at 20 to 30 research centers in China. All eligible patients who sign the informed consent form will be randomly assigned to either the minimalism transcatheter LAAC group or the standard transcatheter LAAC group in a 1:1 ratio. The study will record preoperative baseline information and follow-up data at 7 days post-Procedure or discharge, and at 2, 6, and 12 months post-Procedure, to explore the incidence of procedure-related complications and peridevice leak ≤5mm between the two groups.

Conditions

• Atrial Fibrillation
• Left Atrial Appendage Occlusion
• General Anesthesia
• Local Anesthesia

Interventions

Type	Name	Description
PROCEDURE	Minimalism Transcatheter LAAC Group	Patients will undergo transcatheter LAAC under local anesthesia, guided by DSA and TTE, using the WATCHMAN FLX system. The release criteria (PASS: Position, Anchor, Size, Seal) will be confirmed through DSA and TTE.
PROCEDURE	Standard Transcatheter LAAC Group	Patients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: China