Degenerative Mitral Valve Regurgitation, Functional Mitral Regurgitation, Mitral Regurgitation
Conditions
Brief 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
Interventions
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Sponsors
Xiao-dong Zhuang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amounts of new lesions | 72 hours | Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total new lesion volume | 72 hours | Total new lesion volume assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours |
| Incidence of delirium | 7 days | Incidence of delirium |
| NIHSS worsening | 30 days | NIHSS worsening |
| Incidence of peri- and postprocedural stroke | 30 days | Incidence of peri- and postprocedural stroke |
| Incidences of MACCE at 30 days | 30 days and 1 year | 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) |
Countries
China
Contacts
Primary ContactXiao-dong Zhuang MD
Outcome results
None listed