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| Name | Class |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shenyang Military Region General Hospital of People's Liberation Army | UNKNOWN |
| West China Hospital | OTHER |
This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)
Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.
However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.
Several versions of LAA occlusion devices have been developed.LAA occluder of Shanghai Push Medical Device Technology CO.td, consists of a fixed ball and a cover; The fixed ball composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of the new Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Atrial Appendage Closure Device Group | Experimental | Device:LAmbre Left Atrial Appendage Occluder(Shanghai Push Medical Device Technology CO.td) to close the left atrial appendage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td | Device | Implanting the Occluder to close the left atrial appendage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | 12 months | |
| Successful sealing of the LAA | TEE Criteria | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Component events | death, thromboembolism, device related complication and MACCE | 12 months |
| Complication at puncture site | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li, MD | Contact | 086-15921799351 | 1210874@tongji.edu.cn | |
| Wei Chen, MD, PHD | Contact | 086-21-66308182 | 18917684083@189.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yawei Xu, MD, PHD | Shanghai 10th People's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19683639 | Background | Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X. | |
| 23325525 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Ruijin Hospital |
| OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Fujian Medical University Union Hospital | OTHER |
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| Device performance assessed by TEE/TTE |
| 12 months |
| Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16. |
| 24998121 | Background | Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. |
| 25399274 | Result | Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |