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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06227286
Enrollment
176
Registered
2024-01-26
Start date
2024-03-01
Completion date
2028-12-31
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

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.

Interventions

DEVICEEECP

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

DEVICESham-EECP

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Afterload mismatchWithin 1 years after transcatheter Mitral valve edge-to-edge repairpostoperative-LVEF / preoperative-LVEF \<85% OR postoperative-LVEDVi / preoperative-LVEDVi \>110%

Secondary

MeasureTime frameDescription
Major adverse composite eventsWithin 1 years after transcatheter Mitral valve edge-to-edge repairCardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke

Countries

China

Contacts

Primary ContactXiaodong Zhuang, PhD
zhuangxd3@mail.sysu.edu.cn+86 13760755035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026