WATCHMAN for Second Prevention of Stroke (WASPS)

Stroke Clinical Trial

Official title:

The WASPS Trails:WATCHMAN for Second Prevention of Stroke

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03327350
• Other study ID #: SAHZJU CT009
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 7, 2017
• Last updated: October 26, 2017
• Start date: November 5, 2017
• Est. completion date: November 2020

Study information

• Verified date: January 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting an estimated 5 million Chinese. Atrial fibrillation is the primary cardiac abnormality associated with embolic stroke; among patients with AF, there is an annual stroke rate, about 5 times for the same age population in sinus rhythm.

Although warfarin therapy is effective at reducing the risk of stroke, chronic anticoagulation presents problems of safety and acceptability for many patients. Drug and dietary interactions, frequent blood tests, and compliance issues all contribute to difficulties with chronic warfarin therapy. New oral anticoagulant compounds with better therapeutic range and without need for similar monitoring, such as Dabigatran, Rivaroxaban, Apixaban and Edoxaban,have been studied, but there is no direct comparison with left atrial appendage closure(LAAC).

However,the left atrial appendage (LAA) is the major location of thrombi in patients with AF. In patients with nonrheumatic AF and thrombus in the left atrium, the clot was located in the LAA in 90%. And the 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 thromboembolism in patients with AF.The PROTECT-Af and PREVAIL trails confirmed this device's efficacy and safety, compared with warfarin, for preventing the combined outcome of stroke,systemic embolism, and cardiovascular death. And the device has been approved by China's FDA.

Stroke is the primary cause of death in China, and recurrence of stroke remains a major public health issue.

This cohort study is designed to evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of ischemic stroke in the patients with nonvalvular atrial fibrillation in China, compared with medicine approach (Warfarin or NOAC),.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older;

• A history of stroke/transient ischemic attack(TIA) over 3 months;

• Paroxysmal, persistent, or permanent nonvalvular AF;

• 4.2 or more CHA2DS2-VASc risk factors

• Eligibility for long-term anticoagulation with warfarin or new oral anticoagulants.

Exclusion Criteria:

• patent foramen ovale with atrial septal aneurysm

• an atrial septal defect

• mechanical valve prosthesis

• left ventricular ejection fraction less than 30%

• mobile aortic atheromata

• symptomatic carotid disease

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained)		3 years
Secondary	All the serious complications,including the surgery complications and major bleeding events.		3 years
Secondary	All-cause death		3 years