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CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
Sponsor: Xiao-dong Zhuang
Summary
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices. This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-03-01
Completion Date
2025-10-31
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
Cerebral Embolic Protection
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China