Clinical trial NCT06227286: Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)
Official title: Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Second Affiliated Hospital of Shantou University Medical College
name: Second Affiliated Hospital of Guangzhou Medical University
name: Zhongshan People's Hospital, Guangdong, China
name: Jieyang People's Hospital
First posted: 2024-01-26
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Afterload mismatch
timeFrame: Within 1 years after transcatheter Mitral valve edge-to-edge repair
Secondary outcomes:
measure: Major adverse composite events
timeFrame: Within 1 years after transcatheter Mitral valve edge-to-edge repair
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-Sun University
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xiaodong Zhuang, PhD
role: PRINCIPAL_INVESTIGATOR
References: