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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: EECP; Device: Sham-EECP

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaodong Zhuang, PhD; Phone Number: +86 13760755035; Email: zhuangxd3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • First Affiliated Hospital, Sun Yat-Sen University
      • Contact: Xiaodong Zhuang, PhD; Phone Number: +86 13760755035; Email: zhuangxd3@mail.sysu.edu.cn
    • Guangzhou, Guangdong, China, 510000
      • Second Affiliated Hospital of Guangzhou Medical University
      • Contact: Longgen Xiong; Phone Number: +8613922761639; Email: xionglg66@126.com
    • Guangzhou, Guangdong, China, 510000
      • Third Affiliated Hospital, Sun Yat-Sun University
      • Contact: Zhuoshan Huang, PhD; Phone Number: +86 13728059476; Email: huangzhsh@mail.sysu.edu.cn
    • Jieyang, Guangdong, China, 522000
      • Jieyang People's Hospital
      • Contact: Mingwei Xu, PhD; Phone Number: +86 13828186368; Email: versy@163.com
    • Shantou, Guangdong, China, 515041
      • Second Affiliated Hospital of Shantou University Medical College
      • Contact: Jilin Li, PhD; Phone Number: +86 13592852807; Email: lijilin@126.com
    • Zhongshan, Guangdong, China, 528400
      • Zhongshan People's Hospital
      • Contact: Li Feng, PhD; Phone Number: +86 13902593410; Email: lifengdoc@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EECP Arm; 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.	Device: EECP; EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.
Sham Comparator: Sham-EECP Arm; 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.	Device: Sham-EECP; EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Afterload mismatch	postoperative-LVEF / preoperative-LVEF <85% OR postoperative-LVEDVi / preoperative-LVEDVi >110%	Within 1 years after transcatheter Mitral valve edge-to-edge repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse composite events	Cardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke	Within 1 years after transcatheter Mitral valve edge-to-edge repair

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Third Affiliated Hospital, Sun Yat-Sen University; Second Affiliated Hospital of Guangzhou Medical University; Zhongshan People's Hospital, Guangdong, China; Jieyang People's Hospital; Second Affiliated Hospital of Shantou University Medical College
• Investigators: Principal Investigator: Xiaodong Zhuang, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: PAMPER Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No