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| Name | Class |
|---|---|
| Third Medical Center of Chinese PLA General Hospital | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Ganzhou Municipal Hospital | UNKNOWN |
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This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAMax left atrial appendage occluder | Experimental | Intervention device, LAMax left atrial appendage closure system |
|
| Watchman (control) | Active Comparator | Intervention device, Watchman® LAA Closure Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous left atrial appendage closure-LAMax | Device | Interventional device, LAMax left atrial appendage closure system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful sealing of the LAA | A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE). | 12 months post-implantation |
| Ischemic stroke, TIA, or Systemic embolism | A composite rate of ischemic stroke, TIA or systemic embolism. | 12 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| All stroke, systemic embolism, or cardiovascular/unexplained death | A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death. | 12 months post-implantation |
| Incidence of MACCE events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian-an Wang, MD, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Dongxing Ma, MD | Third Medical Center of Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China | ||
| The Second Hospital of Hebei Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40049930 | Derived | Fan Y, Ma D, Wang C, Luo J, Ling Z, Li S, Peng X, Zhang Z, Chu H, Wang J; investigators in the present study. A Membrane Modification Technique for Left Atrial Appendage Occlusion: A Multicenter Randomized Controlled Trial. JACC Asia. 2025 Mar;5(3 Pt 1):374-387. doi: 10.1016/j.jacasi.2024.12.008. Epub 2025 Feb 18. |
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| First Affiliated Hospital of Guangxi Medical University |
| OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The First Hospital of Jilin University | OTHER |
| LanZhou University | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| The First Municipal hospital of Ningbo | UNKNOWN |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| ShenZhen KYD Biomedical Technology Co., Ltd. | INDUSTRY |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label
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| Percutaneous left atrial appendage closure-Watchman | Device | Interventional device, Watchman® LAA Closure Device |
|
A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.
| 12 months post-implantation |
| Major Bleeding post-device implant | Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition. | 12 months post-implantation |
| Success rate of device collapse and reposition during implantation procedure | It is one of the measures to describe device performance during implantation procedure. | 0 day |
| Rate of cardiac temponade during implantation procedure | It is one of the measures to describe the performance of device and delivery system during implantation procedure. | 0 day |
| Success rate of delivering an occlusion device to the LAA by the delivery system | It is one of the measures to describe the performance of delivery system during implantation procedure. | 0 day |
| Success rate of withdrawing a delivery system after LAAC | It is one of the measures to describe the performance of delivery system. | 0 day |
| Device performance post-implantation | A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation. | 12 months post-implantation |
| Device success rate | A composite rate to describe that the device can be successfully delivered in place and successfully implanted, and angiography shows that the implanted device is in the right position, no residual flow or residual flow is less than 5 mm, and the delivery system can be successfully withdrawn. | 0 day |
| Perioperative clinical success rate | A composite rate to describe that the device's function is normal, including that it was successfully implanted, the residual flow was less than 5mm, the implanted device had no effect on mitral valve movement and pulmonary vein blood flow, and there was no major adverse event (MAE) at the time of discharge. | 7 days post-implantation |
| Shijiazhuang |
| Hebei |
| 050003 |
| China |
| Ganzhou Municipal Hospital | Ganzhou | Jiangxi | 341001 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| The First Municipal hospital of Ningbo | Ningbo | Zhejiang | 315010 | China |
| The Third Medical Center, Chinese People's Liberation Army General Hospital | Beijing | 100039 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | 400010 | China |
| Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | 200011 | China |
| General Hospital of Tianjin Medical University | Tianjin | 300020 | China |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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