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ClinicalTrials.gov ID

NCT06227286

Lead Sponsor

Sun Yat-sen UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

176Estimated

Last Update Posted

Feb 5, 2024Actual

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study

Brief Summary

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.

• Mitral Regurgitation

• EECP
• Sham-EECP

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Third Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Second Affiliated Hospital of Shantou University Medical CollegeOTHER

Second Affiliated Hospital of Guangzhou Medical UniversityOTHER

Zhongshan People's Hospital, Guangdong, ChinaOTHER

Jieyang People's HospitalOTHER

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