Severe pulmonary valve regurgitation following surgical correction of congenital heart disease
Conditions
Interventions
ALL: transcatheter pulmonary valve implantation using VenusP-Valve system
Sponsors
The First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the selected subjects must meet all the following conditions 1. Patients with congenital heart disease with right ventricular outflow tract stenosis had a right ventricular outflow tract (RVOT) and / or a main pulmonary artery patch across the pulmonary valve ring, and moderate to severe pulmonary regurgitation; 2. Right ventricular end diastolic volume index measured by isotope or CMR: 160 ml/m2 >= rvedvi >= 130 ml/m2; 3. Patients over 10 years old and under 60 years old; 4. Patients weighing more than 18 kg; 5. The narrowest diameter of pulmonary artery measured by CT or echocardiography was 20 mm to 34 mm; 6. Imaging (CT or echocardiography) measurement of the main pulmonary artery length >= 20 mm; 7. Informed consent signed by the subject or his legal representative; 8. The attending physician and Venus clinical medical technology center agree that the research object will return for all the required postoperative follow-up, and the research object will comply with the follow-up required by the protocol. Add any of the following: 1. The subjects had symptoms; 2. CMR measurement reflux fraction >= 30%; 3. Pulmonary regurgitation measured by echocardiography >= 3+; 4. RV EF% decreased in progressive right ventricular systolic dysfunction; 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 arrhythmias. *Note: (1) The subjects with symptoms were assessed by NYHA grade II or above, with or without chest tightness, chest pain, palpitation, asthma, and limited activity; (2) Echocardiographic scoring criteria: 1 -There is no color for reflow in any view. -The distance to the right ventricular outflow tract is less than 1.0 cm; -In mild (2 +) cases, the distance to the right ventricular outflow tract was 1.0 to 2.0 cm; -The middle (3 +) ejection distance was more than 2.0 cm and could not reach the right ventricular cavity; -In severe cases (4 +), the ejection distance was more than 2.0 cm, reaching the right ventricular cavity.
Exclusion criteria
Exclusion criteria: 1. The subjects had pre-existing stenosis of pulmonary artery branches that may affect valve implantation or artificial pulmonary valve at any position; 2. Those subjects with severe chest wall deformity (funnel chest, etc.); 3. Patients with acute decompensated heart failure; 4. Patients with active infection or endocarditis who need antibiotic treatment at present; 5. Patients with leukopenia (leukocyte 3.0mg / dl) and / or advanced renal disease requiring renal dialysis were determined by the researcher after comprehensive analysis; 9. According to the judgment of the researcher, it is not feasible to insert the pulmonary valve of Venus P through catheter; 10. Those who are known to be allergic to aspirin or heparin; 11. Female subjects with positive serum pregnancy test; 12. The iliofemoral vessels have the characteristics of influencing the safe placement of the guiding sheath; 13. Patients who had implanted pacemaker or defibrillator or other implants that could not be examined by MRI before operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the reverse remodeling of right ventricle and the improvement rate of right ventricular function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute surgical success rate;Clinical events related to surgery within 48 hours after surgery (death, severe arrhythmia, cardiac tamponage, emergency or emergency changes leading to surgical right ventricular outflow tract, pulmonary perforation rupture, cardiogenic shock, endocarditis, bleeding);All deaths and stroke rates;Changes in imaging and clinical parameters: CMR parameters: corrected RV volume, RV EF, PR severity; Parameters of echocardiography: The position of the artificial pulmonary valve in 2d image and the Doppler flow dynamics were used to determine the RVOT and PV flow velocity, and the pressure difference;Based on the device function evaluated by the researcher, expressed in terms of "rate".;Success rate of operation at discharge at discharge artificial pulmonary valvular function is normal, and no major adverse events (MAE).; | — |
Countries
China
Contacts
Public ContactYang Yining
The First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed