Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban
A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation
1 other identifier
interventional
200
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 atrial-fibrillation
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedSeptember 24, 2015
September 1, 2015
2 years
September 8, 2015
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Combined endpoint
All Stroke or Systemic embolism or Cardiovascular death
2 year
Secondary Outcomes (4)
All bleeding event
2 year
Major bleeding event
2 year
Technical and procedure related event
45 days
Cognitive function change
2 year
Study Arms (2)
WATCHMAN LAA Occlusion Device
EXPERIMENTALSubjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.
Rivaroxaban
ACTIVE COMPARATORSubjects assigned to receive the Rivaroxaban therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Paroxysmal, persistent or permanent non-valvular atrial fibrillation
- Eligible for LAAO and long-term rivaroxaban therapy
- Calculated CHA2DS2-VASc score of 2 or greater.
You may not qualify if:
- Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shulin Wulead
- Wuhan Asia Heart Hospitalcollaborator
- Beijing Anzhen Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Guangdong Medical Collegecollaborator
- First Affiliated Hospital of Jinan Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
Study Sites (9)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
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
Related Publications (3)
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.
PMID: 25399274BACKGROUNDHolmes 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.
PMID: 24998121BACKGROUNDPatel 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.
PMID: 21830957BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Guangdong Cardiovascular Institute
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Last Updated
September 24, 2015
Record last verified: 2015-09