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

Shanghai MicroPort Medical (Group) Co., Ltd.1 site in 1 country210 target enrollmentMarch 3, 2021

ConditionsAtrial Fibrillation Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Enrollment: 210
Locations: 1
Primary Endpoint: Clinical success
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 3, 2021

End Date

September 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non valvular atrial fibrillation subjects aged ≥18 and ≤80;
•High risk of ischemic stroke: CHA2DS2VASc score ≥ 2 ( ≥ 3 for female) together with any of the following circumstances:
•With a recorded history (happened earlier than 6 months from now) of bleeding (including gingival/nasal/oral bleeding, skin \&soft tissue bleeding, gastrointestinal bleeding, urinary tract bleeding, cerebral haemorrhage, etc.) or bleeding tendency;
•Intolerance or rejection of long-term anti-coagulation therapy;
•Suffering stroke or embolism despite routine anti-coagulation therapy;
•With a predicting HAS-BLED score ≥
•Subjects (or his/her legal representatives) are able to understand the study objectives, willing to cooperate with procedure and follow-up. Subjects who voluntarily participate in this trial and have signed the written informed consent form.

Exclusion Criteria

•Subjects with atrial fibrillation (AF) caused by rheumatic valvular disease, moderate to severe mitral stenosis, severe mitral regurgitation, severe aortic valve disease or severe left ventricular outflow tract obstruction with pressure difference greater than 40mmHg;
•Suffering with other disease(s) requiring long-term oral anticoagulation treatment;
•Initial untreated AF, or secondary AF with clear cause (such as hyperthyroid heart disease);
•Intracardiac thrombus (including left and/or right atrium) found or persisted;
•Suffered with myocardial infarction within 3 months;
•History of previous atrial septum repair operation or Atrial Septal Occluder implantation;
•History of previous heart valve (mechanical valve) replacement operation;
•Subjects undergoing heart transplant operation;
•Subjects with symptomatic carotid artery disease (such as carotid stenosis \> 50%) or subjects with vulnerable carotid artery plaque.
•Suffered with ischemic stroke or TIA recently (within 30 days);