RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

NCT06969118 | Not Yet Recruiting DMC

• 1 other identifier: MVS-LAAC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• primary safety

  Occurrence of a composite endpoint about serious perioperative complications including all-cause death, ischemic or hemorrhagic stroke, systemic embolism, and procedure related complications requiring thoracotomy or endovascular intervention treatment.

  7 days after LAAC procedure

• primary efficacy

  Occurrence of successful device implantation under predetermined guidance as well as effective LAA closure with residual leak ≤ 5mm

  From LAAC procedure to the end of treatment at 12 months

Secondary Outcomes (13)

• Stroke/transient ischemic attack and systemic embolism

  at 2, 6, and 12 months post-procedure

• Bleeding events;

  at 2, 6, and 12 months post-procedure

• All-cause death;

  at 2, 6, and 12 months post-procedure

• Cardiac death;

  at 2, 6, and 12 months post-procedure

• Device-related thrombosis events;

  at 2, 6, and 12 months post-procedure

Study Arms (2)

Minimalism Transcatheter LAAC Group

EXPERIMENTAL

Patients underwent LAAC under simplified guidance of TTE and fluoroscopy.

Procedure: Minimalism Transcatheter LAAC Group

Standard Transcatheter LAAC Group

PLACEBO COMPARATOR

Patients underwent LAAC under standard guidance of TEE and fluoroscopy.

Procedure: Standard Transcatheter LAAC Group

Interventions

Minimalism Transcatheter LAAC Group 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.

Minimalism Transcatheter LAAC Group

Standard Transcatheter LAAC Group PROCEDURE

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

Standard Transcatheter LAAC Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 85 years old, all genders;
• 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;
• 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;
• Life expectancy ≥1 year;

You may not qualify if:

• Preoperative TEE/heart CT/intracardiac ultrasound suggested thrombus in the left atrial appendage/left atrium;
• Patients with severe renal insufficiency (creatinine ≥200 μmol/L, creatinine clearance \<30 ml/min);
• Liver disease patients with coagulation abnormalities and clinically relevant bleeding risks, including liver cirrhosis patients reaching Child Pugh stages B and C;
• Severely decreased platelet count at baseline: PLT ≤50\*10\^9/L;
• Patients with severe preoperative cardiac insufficiency (LVEF \<35%; clinical manifestations are uncontrolled class IV heart failure);
• 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;
• 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;
• Patients with concurrent diseases (other than atrial fibrillation) that require anticoagulant therapy (such as after mechanical valve replacement, and spontaneous or recurrent venous thromboembolism);
• Patients who are in clinical trials of other drugs or medical devices and have not completed it yet;
• Patients who are considered ineligible to participate in the clinical trial by the investigator.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital,Fudan Univerisity

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• DAXIN ZHOU, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAXIN ZHOU, MD

CONTACT

8613801641252; zhou.daxin@zs-hospital.sh.cn

SHIQIANG HOU, MD

CONTACT

8613601836857; hou.shiqiang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)