Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban
NCT ID: NCT02549963
Last Updated: 2015-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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WATCHMAN LAA Occlusion Device
Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.
WATCHMAN Left Atrial Appendage Occlusion Device
Rivaroxaban
Subjects assigned to receive the Rivaroxaban therapy.
Rivaroxaban
Interventions
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WATCHMAN Left Atrial Appendage Occlusion Device
Rivaroxaban
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for LAAO and long-term rivaroxaban therapy
* Calculated CHA2DS2-VASc score of 2 or greater.
Exclusion Criteria
* Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
* History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
* History of valvular heart disease.
* Implanted mechanical valve prosthesis.
* New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%.
* Patient has left atrial/left atrial appendage thrombus screened by echocardiography
* Platelet\<100\*109/L or hemoglobin\<100g/L
* Expected lifespan less than 1 years
18 Years
ALL
No
Sponsors
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Wuhan Asia Heart Hospital
OTHER
Beijing Anzhen Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
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
Shulin Wu
OTHER
Responsible Party
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Shulin Wu
Director of Guangdong Cardiovascular Institute
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Nanfang Hospital
Guangzhou, Guangdong, China
The first Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, China
The first affiliated hospital of Jinan university
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The second Affiliated Hospital of Guangzhou medical University
Guangzhou, Guangdong, China
Guangdong Cardiovascular Institute, Guangdong General Hospital
Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Changsheng Ma, M.D. Ph.D.
Role: primary
Xiaobo Huang, M.D. Ph.D.
Role: primary
Wei Wang, M.D.
Role: primary
Aidong Zhang, M.D. Ph.D.
Role: primary
Yugang Dong, M.D. Ph.D.
Role: primary
Shiming Liu, M.D. Ph.D.
Role: primary
Chan Chen, M.D. Ph.D.
Role: primary
Su Xi, M.D. Ph.D.
Role: primary
References
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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.
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.
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.
Other Identifiers
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GDCI 201501
Identifier Type: -
Identifier Source: org_study_id
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