NCT06227286

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Mar 2024Dec 2028

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

January 17, 2024

Last Update Submit

February 2, 2024

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Major adverse composite events

    Within 1 years after transcatheter Mitral valve edge-to-edge repair

Study Arms (2)

EECP Arm

EXPERIMENTAL

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

Sham-EECP Arm

SHAM COMPARATOR

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

Interventions

EECPDEVICE

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

EECP Arm
Sham-EECPDEVICE

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

Sham-EECP Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Third Affiliated Hospital, Sun Yat-Sun University

Guangzhou, Guangdong, 510000, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, 522000, China

Location

Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

Location

Zhongshan People's Hospital

Zhongshan, Guangdong, 528400, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Xiaodong Zhuang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Zhuang, PhD

CONTACT

+86 13760755035zhuangxd3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

CN(6)