Pulmonary Regurgitation
Conditions
Interventions
experimental group:use a transcatheter prosthetic pulmonary valve system (VenusP Valve) to implant the prosthetic pulmonary valve
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Congenital heart disease with right ventricular outflow tract stenosis The subject has a right ventricular outflow tract and/or a main pulmonary artery expansion patch across the pulmonary valve annulus, and moderate to severe pulmonary reflux; 2. Isotope or CMR measurement of right ventricular end diastolic volume index 160mL/m2 >= RVEDVI >= 130mL/m2; 3. Aged >= 10 years and =18 kg; 5. Imaging (CT or echocardiography) measures the diameter of the narrowest part of the pulmonary artery from 20mm to 34mm; 6. Imaging (CT or echocardiography) measures the length of the main pulmonary artery >= 20mm; 7. Patients or their legal representatives signed the informed consent form; 8. The attending doctor and the Venus Clinical Medical Technology Center agree that the subject will return for all required postoperative follow-ups, and the subject will follow the follow-up required by the protocol; 9. Patients who meet the above eight criteria plus any of the following are selected: (1) Subject has symptoms; (2) CMR measurement reflux score >= 30%; (3) Echocardiographic measurement of pulmonary regurgitation >= 3+; (4) Progressive right ventricular systolic dysfunction decreased RV EF%; (5) Progressive tricuspid regurgitation (at least moderate); (6) Complicated with right ventricular outflow tract obstruction (right ventricular systolic pressure>80mmHg); (7) Persistent atrial or ventricular arrhythmia.
Exclusion criteria
Exclusion criteria: 1. The research subject has pre-existing pulmonary artery branch stenosis that may affect valve implantation or artificial pulmonary valve at any position. 2. Severe chest wall deformities (pectus excavatum, etc.). 3. Acute decompensated heart failure. 4. Active infection or endocarditis that currently requires antibiotic treatment. 5. Leukopenia (white blood cell 3.0mg/dl) and/or end-stage renal disease requiring renal dialysis are determined by the investigator after a thorough analysis. 9. According to the judgement of the investigator, it is determined that it is not feasible to introduce the VenusP pulmonary valve via catheter. 10. Known allergy to aspirin or heparin. 11. Female subjects have a positive serum pregnancy test. 12. The iliac femoral blood vessels have characteristics that affect the safe placement of the introducer sheath. 13. Pacemaker or defibrillator or other implants that cannot be examined by MRI have been implanted before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The right ventricular reverse remodeling and the improvement rate of right ventricular function were followed up for 6 months after the operation, defined as the right ventricular end-diastolic volume index measured by CMR at the 6-month follow-up, which was within the normal range, that is, RVEDVI<=108mL/m2;Surgical success rate at discharge; | — |
Countries
China
Contacts
Public ContactZhou Daxin
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed