RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

NCT ID: NCT06969118

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Minimalism Transcatheter LAAC Group

Patients underwent LAAC under simplified guidance of TTE and fluoroscopy.

Group Type: EXPERIMENTAL

Minimalism Transcatheter LAAC Group

Intervention Type: PROCEDURE

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.

Standard Transcatheter LAAC Group

Patients underwent LAAC under standard guidance of TEE and fluoroscopy.

Group Type: PLACEBO_COMPARATOR

Standard Transcatheter LAAC Group

Intervention Type: PROCEDURE

Patients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18 - 85 years old, all genders;

2. Subjects who can understand the purpose of the trial, participate voluntarily and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements;

3. Indications for left atrial appendage closure: non-valvular atrial fibrillation patients with CHA2DS2-VAS2 score ≥2 and HAS-BLED score ≥3, or who are unable or unwilling to receive long-term oral anticoagulants;

4. Life expectancy ≥1 year;

Exclusion Criteria

1. Preoperative TEE/heart CT/intracardiac ultrasound suggested thrombus in the left atrial appendage/left atrium;

2. Patients with severe renal insufficiency (creatinine ≥200 μmol/L, creatinine clearance <30 ml/min);

3. Liver disease patients with coagulation abnormalities and clinically relevant bleeding risks, including liver cirrhosis patients reaching Child Pugh stages B and C;

4. Severely decreased platelet count at baseline: PLT ≤50*10^9/L;

5. Patients with severe preoperative cardiac insufficiency (LVEF <35%; clinical manifestations are uncontrolled class IV heart failure);

6. Combined with other severe cardiac valvular diseases or other structural abnormalities that require surgical treatment on an elective day; or severe coronary heart disease that requires intervention within a fixed period;

7. Patients who have lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injuries, recent brain, spinal or ophthalmic procedure, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular malformations;

8. Patients with concurrent diseases (other than atrial fibrillation) that require anticoagulant therapy (such as after mechanical valve replacement, and spontaneous or recurrent venous thromboembolism);

9. Patients who are in clinical trials of other drugs or medical devices and have not completed it yet;

10. Patients who are considered ineligible to participate in the clinical trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DAXIN ZHOU, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital,Fudan Univerisity

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

DAXIN ZHOU, MD

Role: CONTACT

zhou.daxin@zs-hospital.sh.cn

8613801641252

SHIQIANG HOU, MD

Role: CONTACT

hou.shiqiang@zs-hospital.sh.cn

8613601836857

Facility Contacts

XIAOCHUN ZHANG, MD

Role: primary

zhang.xiaochun@zs-hospital.sh.cn

8615002121366

DAXIN ZHOU, MD

Role: backup

zhou.daxin@zs-hospital.sh.cn

8613801641252

Other Identifiers

MVS-LAAC

Identifier Type: -

Identifier Source: org_study_id