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

NCT06227286 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2024-02-05

No results posted yet for this 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.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

EECP

EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.

DEVICE

Sham-EECP

EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Second Affiliated Hospital of Shantou University Medical College

    collaborator OTHER

  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Jieyang People's Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xiaodong Zhuang, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227286 on ClinicalTrials.gov