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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02549963

Enrollment

200

Registered

2015-09-15

Start date

2015-10-31

Completion date

Unknown

Last updated

2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

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.

Interventions

DEVICEWATCHMAN Left Atrial Appendage Occlusion Device

DRUGRivaroxaban

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Combined endpoint	2 year	All Stroke or Systemic embolism or Cardiovascular death

Secondary

Measure	Time frame	Description
All bleeding event	2 year	Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
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

Countries

China

Contacts

Primary ContactShulin Wu, M.D. Ph.D.

doctorwushulin@163.com+8613902255336

Backup ContactXianhong Fang, M.D. Ph.D.

fangxianhong2000@sina.com862083827812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026