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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Mitral Regurgitation

Treatments: Device: Sham-EECP; Device: EECP

Study type: Interventional

Funder types: Other

Identifiers

NCT06227286

PAMPER Study

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

EECP Arm

Experimental group

Description:

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.

Treatment:

Device: EECP

Sham-EECP Arm

Sham Comparator group

Description:

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.

Treatment:

Device: Sham-EECP