Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

Phase 4

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Drug: Rivaroxaban; Device: WATCHMAN Left Atrial Appendage Occlusion Device

• Registration Number: NCT02549963
• Lead Sponsor: Shulin Wu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-13
• Study First Posted: 2015-09-15
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-24
• Study Start: 2015-10
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban	Subjects assigned to receive the Rivaroxaban therapy.
WATCHMAN LAA Occlusion Device	WATCHMAN Left Atrial Appendage Occlusion Device	Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.

Primary Outcome Measures

Name	Time	Method
Combined endpoint	2 year	All Stroke or Systemic embolism or Cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Major bleeding event	2 year	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
Technical and procedure related event	45 days	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.
Cognitive function change	2 year	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
All bleeding event	2 year	Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.

Trial Locations

Locations (9)

The second Affiliated Hospital of Guangzhou medical University; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Cardiovascular Institute, Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

The first Affiliated Hospital of Guangzhou medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The Affiliated Hospital of Guangdong Medical College; 🇨🇳 Zhanjiang, Guangdong, China

The first affiliated hospital of Jinan university; 🇨🇳 Guangzhou, Guangdong, China