CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total amounts of new lesions
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total amounts of new lesions
时间窗: 72 hours
Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
次要结局
- Total new lesion volume(72 hours)
- Incidence of delirium(7 days)
- NIHSS worsening(30 days)
- Incidence of peri- and postprocedural stroke(30 days)
- Incidences of MACCE at 30 days(30 days and 1 year)
研究者
Xiao-dong Zhuang
Dr.
Sun Yat-sen University