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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
210
Implant LAAC system in LAA through percutaneous intervention
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Clinical success
Freedom from ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death and unexplained death
Time frame: 12-month
LAA occlusion success
TEE examination showing that the residual shunt \< 5mm jet width or complete occlusion of LAA
Time frame: 12-month
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