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Clinical Trials in China / NCT06227286
Starting soon Not applicable

Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)

NCT06227286 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2024-03-01
Last updated
2024-02-05

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

EECPSham-EECP

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 outcome measure(s)

  • Prevalence of Afterload mismatch — Within 1 years after transcatheter Mitral valve edge-to-edge repair
    postoperative-LVEF / preoperative-LVEF \<85% OR postoperative-LVEDVi / preoperative-LVEDVi \>110%

Trial sites (6)

FacilityCityRegionStatus
First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong
Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Third Affiliated Hospital, Sun Yat-Sun University Guangzhou Guangdong
Jieyang People's Hospital Jieyang Guangdong
Second Affiliated Hospital of Shantou University Medical College Shantou Guangdong
Zhongshan People's Hospital Zhongshan Guangdong

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Other trials for the same condition

CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair Starting soon
Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER). Recruiting
Valveclip® Transcatheter Mitral Valve Repair Study Recruiting
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant Recruiting
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06227286 on ClinicalTrials.gov ↗ ← All trials in China