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Not yet recruiting NCT06227286

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

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EECP, Sham-EECP.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Prevalence of Afterload mismatch [Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair]
Secondary outcome measures (1)
  • Major adverse composite events [Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 6 centers
  • First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
  • Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Third Affiliated Hospital, Sun Yat-Sun University — Guangzhou
  • Jieyang People's Hospital — Jieyang
  • Second Affiliated Hospital of Shantou University Medical College — Shantou
  • Zhongshan People's Hospital — Zhongshan

Identifiers

NCT: NCT06227286 · PAMPER Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗