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.
Age ≥18 years
Severe Mitral Regurgitation (3+ to 4+)
Symptom status: NYHA functional class ≥ II
Subjects scheduled to receive the M-TEER per the current approved indications for use
Contraindication to MRI
CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
Xiao-dong Zhuang
Lead sponsor
Sun Yat-sen University
Sponsor institution