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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06227286
• Other study ID #: PAMPER Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: Xiaodong Zhuang, PhD
• Phone: +86 13760755035
• Email: zhuangxd3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.
• Sham-EECP
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Third Affiliated Hospital, Sun Yat-Sun University	Guangzhou	Guangdong
China	Jieyang People's Hospital	Jieyang	Guangdong
China	Second Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Zhongshan People's Hospital	Zhongshan	Guangdong

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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