Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 6
- 主要终点
- Prevalence of Afterload mismatch
研究概览
简要总结
The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER). The main questions it aims to answer are: (1) can enhanced external counterpulsation (EECP) reduce the prevalence of afterload mismatch after TEER? (2) can EECP prevent the major adverse cardiac events after TEER? Participants will be randomly assigned into EECP or Sham-EECP intervention after TEER. Researchers will compare the EECP and Sham-EECP to see if it helps reduce the prevalence of afterload mismatch after TEER.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate
- •Age > 18 years
- •Moderate or severe Mitral Regurgitation
- •Patients who meet the indications for transcatheter Mitral valve edge-to-edge repair and have undergone TEERM
排除标准
- •Lower extremity deep vein thrombosis, active thrombophlebitis
- •Moderate or severe aortic stenosis/insufficiency
- •Moderate pulmonary hypertension (mean pulmonary pressure >50mmHg)
- •Aortic aneurysm/cerebral aneurysm Uncontrolled hypertension (>180/110mmHg) Arrhythmias that may interfere with the ECG gating function of the EECP device Hemorrhagic disease or obvious bleeding tendency Limb infection Pregnant/lactating women
结局指标
主要结局
Prevalence of Afterload mismatch
时间窗: Within 1 years after transcatheter Mitral valve edge-to-edge repair
postoperative-LVEF / preoperative-LVEF \<85% OR postoperative-LVEDVi / preoperative-LVEDVi \>110%
次要结局
- Major adverse composite events(Within 1 years after transcatheter Mitral valve edge-to-edge repair)
研究者
Xiao-dong Zhuang
Professor
Sun Yat-sen University