Clinical trial NCT02549963: Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Asia Heart Hospital
name: Beijing Anzhen Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Second Affiliated Hospital of Guangzhou Medical University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Guangdong Medical College
name: First Affiliated Hospital of Jinan University
name: Nanfang Hospital, Southern Medical University
First posted: 2015-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Combined endpoint
timeFrame: 2 year
Secondary outcomes:
measure: All bleeding event
timeFrame: 2 year
measure: Major bleeding event
timeFrame: 2 year
measure: Technical and procedure related event
timeFrame: 45 days
measure: Cognitive function change
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The first Affiliated Hospital of Guangzhou medical University
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of Jinan university
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The second Affiliated Hospital of Guangzhou medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute, Guangdong General Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: The Affiliated Hospital of Guangdong Medical College
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.