Atrial FibrillationNCT06969118
RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients
A study testing Minimalism Transcatheter LAAC Group and Standard Transcatheter LAAC Group in people with Atrial Fibrillation and Left Atrial Appendage Occlusion, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Occlusion, General Anesthesia
- What is being tested?
- Minimalism Transcatheter LAAC Group and Standard Transcatheter LAAC Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital,Fudan Univerisity
Shanghai, Shanghai Municipality, 200032
XIAOCHUN ZHANG, MD, 8615002121366, zhang.xiaochun@zs-hospital.sh.cn
DAXIN ZHOU, MD, 8613801641252, zhou.daxin@zs-hospital.sh.cn
About this study
Official title: A Multi-center, Randomized, Controlled Study Comparing Minimalist Procedure With Standard Procedure for Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation
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.
Read the 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
- Being tested
- Minimalism Transcatheter LAAC Group, Standard Transcatheter LAAC Group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimalism Transcatheter LAAC GroupProcedure or surgery
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 GroupProcedure or surgery
Patients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual.
| Study group | Role | What they receive |
|---|---|---|
| Minimalism Transcatheter LAAC Group | Experimental | Patients underwent LAAC under simplified guidance of TTE and fluoroscopy. Receives: Procedure: Minimalism Transcatheter LAAC Group |
| Standard Transcatheter LAAC Group | Placebo comparator | Patients underwent LAAC under standard guidance of TEE and fluoroscopy. Receives: Procedure: Standard Transcatheter LAAC Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From LAAC procedure to the end of treatment at 12 months
Secondary outcomes (13)
Stroke/transient ischemic attack and systemic embolism
Occurrence of stroke/transient ischemic attack and systemic embolism
Measured: at 2, 6, and 12 months post-procedure
Bleeding events;
Occurrence of bleeding events
Measured: at 2, 6, and 12 months post-procedure
All-cause death;
Occurrence of all-cause death
Measured: at 2, 6, and 12 months post-procedure
Cardiac death;
Occurrence of cardiac death
Measured: at 2, 6, and 12 months post-procedure
Device-related thrombosis events;
Occurrence of device-related thrombosis events
Measured: at 2, 6, and 12 months post-procedure
Immediate procedure success rate
The occurrence rate of successful device implantation under predetermined guidance
Measured: Perioperation
The duration of the procedure
The duration of the LAAC procedure (minutes)
Measured: Perioperation
the amount of contrast medium
the amount of intraoperative contrast medium (ml)
Measured: Perioperation
the amount of radiation
the amount of intraoperative radiation (Gy)
Measured: Perioperation
hospitalization time
hospitalization time (days)
Measured: Perioperation
The number of replacements of the device.
The number of replacements of the device.
Measured: Perioperation
All procedure-related complications
Occurrence of all procedure-related complications
Measured: at 2, 6, and 12 months post-procedure
Effective LAA closure
The occurrence rate of effective LAA closure (residual leak ≤5mm)
Measured: at 2, 6, and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAXIN ZHOU, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969118
- Sponsor's protocol ID
- MVS-LAAC
- Status last verified
- May 2025
- First submitted
- 30 Aug 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled Study Comparing Minimalist Procedure With Standard Procedure for Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06969118
- Acronym / sponsor ID
- MVS-LAAC
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Occlusion, General Anesthesia, Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimalism Transcatheter LAAC Group | Experimental | Procedure: Minimalism Transcatheter LAAC GroupPatients underwent LAAC under simplified guidance of TTE and fluoroscopy. |
| Standard Transcatheter LAAC Group | Placebo comparator | Procedure: Standard Transcatheter LAAC GroupPatients underwent LAAC under standard guidance of TEE and fluoroscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimalism Transcatheter LAAC GroupPatients 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 or surgery | Minimalism Transcatheter LAAC Group |
| Standard Transcatheter LAAC GroupPatients will undergo LAAC under general anesthesia, guided by TEE, using the WATCHMAN FLX system, following the steps outlined in the product manual. | Procedure or surgery | Standard Transcatheter LAAC Group |
Primary outcome
primary safety
Time frame: 7 days after LAAC procedure
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.
primary efficacy
Time frame: From LAAC procedure to the end of treatment at 12 months
Occurrence of successful device implantation under predetermined guidance as well as effective LAA closure with residual leak ≤ 5mm
13 secondary outcomes
Stroke/transient ischemic attack and systemic embolism
Time frame: at 2, 6, and 12 months post-procedure
Bleeding events;
Time frame: at 2, 6, and 12 months post-procedure
All-cause death;
Time frame: at 2, 6, and 12 months post-procedure
Cardiac death;
Time frame: at 2, 6, and 12 months post-procedure
Device-related thrombosis events;
Time frame: at 2, 6, and 12 months post-procedure
Immediate procedure success rate
Time frame: Perioperation
The duration of the procedure
Time frame: Perioperation
the amount of contrast medium
Time frame: Perioperation
the amount of radiation
Time frame: Perioperation
hospitalization time
Time frame: Perioperation
The number of replacements of the device.
Time frame: Perioperation
All procedure-related complications
Time frame: at 2, 6, and 12 months post-procedure
Effective LAA closure
Time frame: at 2, 6, and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DAXIN ZHOU, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimalism Transcatheter LAAC Group and Standard Transcatheter LAAC Group in people with Atrial Fibrillation and Left Atrial Appendage Occlusion, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAXIN ZHOU, MD (8613801641252, zhou.daxin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary safety (time frame: 7 days after LAAC procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.