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WATCHMAN for Second Prevention of Stroke (WASPS)

NCT03327350 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2017-10-31

No results posted yet for this study

Summary

To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation

Conditions

Interventions

DEVICE

WATCHMAN transplantation

WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic

DRUG

Oral anticoagulant drugs

This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).For patients taking warfarin,international normalizedratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Followup visits occurred twice annually after the first year,with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jian-an Wang, MD,PhD · Second Affiliated Hospital of Zhejiang University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-05
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03327350 on ClinicalTrials.gov