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.
Subjects with indications for M-TEER and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with M-TEER or 2) Control: Unprotected M-TEER. Enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (DW-MRI) at baseline and at 72 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days. The study aims to address: * To determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group. * To assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after M-TEER * To explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function * To evaluate the histopathological features of the captured fragments and their relevance to clinical features
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Total amounts of new lesions
Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
Time frame: 72 hours
Total new lesion volume
Total new lesion volume assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours
Time frame: 72 hours
Incidence of delirium
Incidence of delirium
Time frame: 7 days
NIHSS worsening
NIHSS worsening
Time frame: 30 days
Incidence of peri- and postprocedural stroke
Incidence of peri- and postprocedural stroke
Time frame: 30 days
Incidences of MACCE at 30 days
The incidences of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3, including renal replacement therapy)
Time frame: 30 days and 1 year
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