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Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke — SAFE-PROTECT  

Stroke Clinical Trial

Official title:
Safety And EFficacy of Using LEft Atrium APpendage Closure in Nonvalvular AtRial FibrillatiOn PatienTs With High Risk of ischEmiC sTroke -- A Prospective Multicenter Randomized Clinical Trial

Clinical Trial Summary

To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. And to support registration approval from National Medical Products Administration (NMPA).

Clinical Trial Description

SAFE-PROTECT trial is composed of Roll-in group, small-size group and RCT group. This trial is planned to conduct in about 20 sites from China. Roll-in group plans to enroll at most 3 subjects each site to implant experimental device for exploration and observation. RCT group plans to enroll no less than 210 subjects who meet the inclusion/exclusion criteria, and 1:1 randomly allocated to experimental arm or comparator arm. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04479722
Study type Interventional
Source Shanghai MicroPort Medical (Group) Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date March 3, 2021
Completion date September 30, 2026
View Details
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