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| Name | Class |
|---|---|
| Wuhan Asia Heart Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Second Affiliated Hospital of Guangzhou Medical University |
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This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WATCHMAN LAA Occlusion Device | Experimental | Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device. |
|
| Rivaroxaban | Active Comparator | Subjects assigned to receive the Rivaroxaban therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN Left Atrial Appendage Occlusion Device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint | All Stroke or Systemic embolism or Cardiovascular death | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| All bleeding event | Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment. | 2 year |
| Major bleeding event | An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shulin Wu, M.D. Ph.D. | Contact | +8613902255336 | doctorwushulin@163.com | |
| Xianhong Fang, M.D. Ph.D. | Contact | 862083827812 | 10512 | fangxianhong2000@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25399274 | Background | 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. | |
| 24998121 |
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| OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Guangdong Medical College | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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| Rivaroxaban | Drug |
|
|
| 2 year |
| Technical and procedure related event | A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or thrombus of the device with a consequent cardioembolic event. | 45 days |
| Cognitive function change | Montreal Cognitive Assessment(MoCA) will be performed to detect cognitive function change.The differences between the MoCA test score in WATCHMAN group and in a control group of Rivaroxaban | 2 year |
| Nanfang Hospital | Guangzhou | Guangdong | 510000 | China |
|
| The first Affiliated Hospital of Guangzhou medical University | Guangzhou | Guangdong | 510000 | China |
|
| The first affiliated hospital of Jinan university | Guangzhou | Guangdong | 510000 | China |
|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
|
| The second Affiliated Hospital of Guangzhou medical University | Guangzhou | Guangdong | 510000 | China |
|
| Guangdong Cardiovascular Institute, Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| The Affiliated Hospital of Guangdong Medical College | Zhanjiang | Guangdong | 524000 | China |
|
| Wuhan Asia Heart Hospital | Wuhan | Hubei | 430000 | China |
|
| 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. |
| 21830957 | Background | Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C065145 | N(4)-oleylcytosine arabinoside |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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