NCT06227286

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation

Interventions

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

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-01-26
• Last updated: 2024-02-05

Locations

6 sites across 1 country: China