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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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.
Patients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual.
Zhongshan Hospital,Fudan Univerisity
Shanghai, Shanghai Municipality, China
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.
Time frame: 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
Time frame: From LAAC procedure to the end of treatment at 12 months
Stroke/transient ischemic attack and systemic embolism
Occurrence of stroke/transient ischemic attack and systemic embolism
Time frame: at 2, 6, and 12 months post-procedure
Bleeding events;
Occurrence of bleeding events
Time frame: at 2, 6, and 12 months post-procedure
All-cause death;
Occurrence of all-cause death
Time frame: at 2, 6, and 12 months post-procedure
Cardiac death;
Occurrence of cardiac death
Time frame: at 2, 6, and 12 months post-procedure
Device-related thrombosis events;
Occurrence of device-related thrombosis events
Time frame: at 2, 6, and 12 months post-procedure
Immediate procedure success rate
The occurrence rate of successful device implantation under predetermined guidance
Time frame: Perioperation
The duration of the procedure
The duration of the LAAC procedure (minutes)
Time frame: Perioperation
the amount of contrast medium
the amount of intraoperative contrast medium (ml)
Time frame: Perioperation
the amount of radiation
the amount of intraoperative radiation (Gy)
Time frame: Perioperation
hospitalization time
hospitalization time (days)
Time frame: Perioperation
The number of replacements of the device.
The number of replacements of the device.
Time frame: Perioperation
All procedure-related complications
Occurrence of all procedure-related complications
Time frame: at 2, 6, and 12 months post-procedure
Effective LAA closure
The occurrence rate of effective LAA closure (residual leak ≤5mm)
Time frame: at 2, 6, and 12 months post-procedure
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