Clinical trial NCT03327350: WATCHMAN for Second Prevention of Stroke (WASPS)
Official title: The WASPS Trails:WATCHMAN for Second Prevention of Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 hospitalized patients over 18 years old with nonvalvular atrial fibrillation will be enrolled consecutively

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

Detailed 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),.

Eligibility criteria: 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

Primary outcomes:
measure: All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained)
timeFrame: 3 years
Secondary outcomes:
measure: All the serious complications,including the surgery complications and major bleeding events.
timeFrame: 3 years
measure: All-cause death
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Jian-an Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: