Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)
NCT ID: NCT06227286
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
176 participants
INTERVENTIONAL
2024-03-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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EECP Arm
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.
EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.
Sham-EECP Arm
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.
Sham-EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.
Interventions
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EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.
Sham-EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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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
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Jieyang People's Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Xiao-dong Zhuang
Professor
Principal Investigators
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Xiaodong Zhuang, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Third Affiliated Hospital, Sun Yat-Sun University
Guangzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PAMPER Study
Identifier Type: -
Identifier Source: org_study_id
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