CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

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

Inclusion criteria

Subjects must meet ALL of the following criteria:

General Inclusion Criteria

• 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
• Subjects agreed to join the study and complete follow-up

Exclusion criteria

Potential Subjects will be excluded if ANY of the following criteria apply:

General Exclusion Criteria

• 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
• Cerebrovascular accident within prior 30 days
• Severe symptomatic carotid stenosis (>70% by ultrasound)
• Carotid surgery or stenting within prior 30 days
• Hemodynamic instability requiring inotropic support or mechanical heart assistance
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
• Contraindication for transesophageal echocardiography
• Life expectancy < 1 year
• Pregnant or planning pregnancy within next 12 months
• Participation in another interventional Trial
• Patients who are not able to give consent or complete the follow-up