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

Not Applicable

Not yet recruiting

• Conditions: Mitral Regurgitation
• Interventions: Device: EECP; Device: Sham-EECP

• Registration Number: NCT06227286
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Study Start: 2024-03-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EECP Arm	EECP	Participants would be assigned for treating with EECP initiated with 0.030 MPa, 30-45 minutes per day, 5 days per week, 7 weeks in total.
Sham-EECP Arm	Sham-EECP	Participants would be assigned for treating with Sham-EECP initiated with 70 mmHg, 30-45 minutes per day, 5 days per week, 7 weeks in total.

Primary Outcome Measures

Name	Time	Method
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%

Secondary Outcome Measures

Name	Time	Method
Major adverse composite events	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

Trial Locations

Locations (6)

Third Affiliated Hospital, Sun Yat-Sun University; 🇨🇳 Guangzhou, Guangdong, China

Jieyang People's Hospital; 🇨🇳 Jieyang, Guangdong, China

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

Second Affiliated Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China

Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan People's Hospital; 🇨🇳 Zhongshan, Guangdong, China