A prospective, multi-center, randomized, pilot study of the watchman left atrial appendage occlusion device in patients with non-valvular atrial fibrillation versus rivaroxaban therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-PPR-15007044

Enrollment

Unknown

Registered

2015-09-08

Start date

2015-09-16

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

atrial fibrillation

Interventions

Experimental:WATCHMAN LAA Occlusion Device

Active Comparator:Rivaroxaban

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Older than 18 years; 2. ECG or holter evidence for af; 3. cha2ds2-vasc score>=2; 4. accept laao or noac to prevent stroke; 5. written informed consent.

Exclusion criteria

Exclusion criteria: 1. contraindicated/allergic to aspirin, clopidogrel novel oral anticoagulants; 2. history of atrial septal repair or implantation with asd/pfo device; 3. history of valvular heart disease; 4. implanted mechanical valve; 5. nyha class iv chf or lvef less than 30%; 6. patient has left atrial/left atrial appendage thrombus screened by echocardiography; 7. platelet<100*10^9/l or hemoglobin<100g/l; 8. expected lifespan less than 1 years.

Design outcomes

Primary

Measure	Time frame
ischemic stroke;systemic embolism;cardiovascular death;	—

Secondary

Measure	Time frame
Major bleeding events;Al bleeding events;Technical and Procedure related events;Cognitive function change;	—

Countries

China

Contacts

Public Contactshulin wu

doctorwushulin@163.com+86 13902255336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026