NCT06814210

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Xiao-dong Zhuang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Mitral Regurgitation
• Functional Mitral Regurgitation
• Degenerative Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Cerebral Embolic Protection	Subjects will undergo M-TEER following placement of the cerebral embolic protection device.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-30
• Completion: 2025-10-31
• First posted: 2025-02-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: China