NCT02549963
Unknown
Phase 4
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
Shulin Wu9 sites in 1 country200 target enrollmentOctober 2015
DrugsRivaroxaban
Overview
- Phase
- Phase 4
- Intervention
- WATCHMAN Left Atrial Appendage Occlusion Device
- Conditions
- Atrial Fibrillation
- Sponsor
- Shulin Wu
- Enrollment
- 200
- Locations
- 9
- Primary Endpoint
- Combined endpoint
- Last Updated
- 10 years ago
Overview
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.
Investigators
Shulin Wu
Director of Guangdong Cardiovascular Institute
Guangdong Provincial People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Paroxysmal, persistent or permanent non-valvular atrial fibrillation
- •Eligible for LAAO and long-term rivaroxaban therapy
- •Calculated CHA2DS2-VASc score of 2 or greater.
Exclusion Criteria
- •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
Arms & Interventions
WATCHMAN LAA Occlusion Device
Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.
Intervention: WATCHMAN Left Atrial Appendage Occlusion Device
Rivaroxaban
Subjects assigned to receive the Rivaroxaban therapy.
Intervention: Rivaroxaban
Outcomes
Primary Outcomes
Combined endpoint
Time Frame: 2 year
All Stroke or Systemic embolism or Cardiovascular death
Secondary Outcomes
- Major bleeding event(2 year)
- Technical and procedure related event(45 days)
- Cognitive function change(2 year)
- All bleeding event(2 year)
Study Sites (9)
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