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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Second Affiliated Hospital of Shantou University Medical College | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EECP Arm | Experimental | Participants would be assigned for treating with EECP initiated with 0.030 MPa, 30-45 minutes per day, 5 days per week, 7 weeks in total. |
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| Sham-EECP Arm | Sham Comparator | Participants would be assigned for treating with Sham-EECP initiated with 70 mmHg, 30-45 minutes per day, 5 days per week, 7 weeks in total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EECP | Device | EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Afterload mismatch | postoperative-LVEF / preoperative-LVEF <85% OR postoperative-LVEDVi / preoperative-LVEDVi >110% | Within 1 years after transcatheter Mitral valve edge-to-edge repair |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse composite events | Cardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke | Within 1 years after transcatheter Mitral valve edge-to-edge repair |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Zhuang, PhD | Contact | +86 13760755035 | zhuangxd3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaodong Zhuang, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Jieyang People's Hospital | OTHER |
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| Sham-EECP |
| Device |
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg. |
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| Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
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| Third Affiliated Hospital, Sun Yat-Sun University | Guangzhou | Guangdong | 510000 | China |
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| Jieyang People's Hospital | Jieyang | Guangdong | 522000 | China |
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| Second Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | 515041 | China |
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| Zhongshan People's Hospital | Zhongshan | Guangdong | 528400 | China |
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