Stroke Clinical Trial - WATCHMAN for Second Prevention of Stroke (WASPS)

Status Enrolling by invitation

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

Clinical Trial 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),. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03327350
Study type	Observational
Source	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	November 5, 2017
Completion date	November 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.