RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Minimalism Transcatheter LAAC Group
Procedure/SurgeryPatients 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
Procedure/SurgeryPatients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Minimalism Transcatheter LAAC GroupExperimental treatment 1 intervention
Group B: Standard Transcatheter LAAC GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 procedure2
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 monthsSecondary outcomes
1
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-procedure2
Bleeding events;
Occurrence of bleeding events
Time frame
at 2, 6, and 12 months post-procedure3
All-cause death;
Occurrence of all-cause death
Time frame
at 2, 6, and 12 months post-procedure4
Cardiac death;
Occurrence of cardiac death
Time frame
at 2, 6, and 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov
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