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Not yet recruitingNCT06969118Updated May 13, 2025

RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

An interventional study of Minimalism Transcatheter LAAC Group and Standard Transcatheter LAAC Group in Atrial Fibrillation, Left Atrial Appendage Occlusion and General Anesthesia, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

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

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 200 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

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Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Minimalism Transcatheter LAAC Group

    Patients underwent LAAC under simplified guidance of TTE and fluoroscopy.

    Procedure: Minimalism Transcatheter LAAC Group

  • Placebo comparator
    Standard Transcatheter LAAC Group

    Patients underwent LAAC under standard guidance of TEE and fluoroscopy.

    Procedure: Standard Transcatheter LAAC Group

Interventions

  • ProcedureMinimalism 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.

  • ProcedureStandard 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.

06

What researchers measure

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 procedure

  2. 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

Secondary 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-procedure

  2. Bleeding events;

    Occurrence of bleeding events

    Time frame: at 2, 6, and 12 months post-procedure

  3. All-cause death;

    Occurrence of all-cause death

    Time frame: at 2, 6, and 12 months post-procedure

  4. Cardiac death;

    Occurrence of cardiac death

    Time frame: at 2, 6, and 12 months post-procedure

  5. Device-related thrombosis events;

    Occurrence of device-related thrombosis events

    Time frame: at 2, 6, and 12 months post-procedure

  6. Immediate procedure success rate

    The occurrence rate of successful device implantation under predetermined guidance

    Time frame: Perioperation

  7. The duration of the procedure

    The duration of the LAAC procedure (minutes)

    Time frame: Perioperation

  8. the amount of contrast medium

    the amount of intraoperative contrast medium (ml)

    Time frame: Perioperation

  9. the amount of radiation

    the amount of intraoperative radiation (Gy)

    Time frame: Perioperation

  10. hospitalization time

    hospitalization time (days)

    Time frame: Perioperation

  11. The number of replacements of the device.

    The number of replacements of the device.

    Time frame: Perioperation

  12. All procedure-related complications

    Occurrence of all procedure-related complications

    Time frame: at 2, 6, and 12 months post-procedure

  13. Effective LAA closure

    The occurrence rate of effective LAA closure (residual leak ≤5mm)

    Time frame: at 2, 6, and 12 months post-procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Jun 2027, 24 months later.

Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 24 months is below that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2024
First posted
May 13, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 1, 2027
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06969118
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
May 13, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
May 13, 2025

Study contacts

DAXIN ZHOU, MD
Contact
zhou.daxin@zs-hospital.sh.cn
8613801641252
SHIQIANG HOU, MD
Contact
hou.shiqiang@zs-hospital.sh.cn
8613601836857
DAXIN ZHOU, MD
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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