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NCT Number: NCT06227286

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EECP

Device

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

Sham-EECP

Device

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

Primary outcomes

  1. Prevalence of Afterload mismatch

    Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair

    postoperative-LVEF / preoperative-LVEF <85% OR postoperative-LVEDVi / preoperative-LVEDVi >110%

Secondary outcomes

  1. Major adverse composite events

    Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair

    Cardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Zhuang, PhD

CONTACT

[email protected]

+86 13760755035

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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