NCT04479722

Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	Left atrial appendage closure procedure	Implant LAAC system in LAA through percutaneous intervention

Timeline

• Start date: 2021-03-03
• Primary completion: 2022-09-27
• Completion: 2026-09-30
• First posted: 2020-07-21
• Last updated: 2023-10-23

Locations

1 site across 1 country: China