Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Right Ventricular Outflow Tract Stenosis
- Sponsor
- Venus MedTech (HangZhou) Inc.
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Improvement rate of RVEDV at 6 months post-procedure.
- Last Updated
- 11 years ago
Overview
Brief Summary
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
Detailed Description
The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve. Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI) between 130-160mL/m2. Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation
- •Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2
- •Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years
- •Body weight≥18 kg
- •Pulmonary annular diameter between 14mm to 31mm
- •RVOT length≥20mm
- •The subject or his/her legal representative has provided written informed consent
- •Subject will comply with protocol required follow-ups
- •Add any of the following conditions:
- •Subject is symptomatic
Exclusion Criteria
- •Candidates will be excluded from the study if any of the following conditions are present:
- •Existing pulmonary artery branch stenosis or artificial pulmonary valve
- •Severe chest wall deformity
- •Active infection or endocarditis requiring antibiotic therapy
- •Leukopenia (WBC\<3000mm3)
- •Acute or chronic anemia (Hb\<9g/L)
- •Platelet account \<100,000 cells/mm3
- •In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
- •A known hypersensitivity to aspirin or heparin
- •Positive urine or serum pregnancy test in female subjects
Outcomes
Primary Outcomes
Improvement rate of RVEDV at 6 months post-procedure.
Time Frame: At 6 months post-implantation of Venus-P valve
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
Secondary Outcomes
- Safety Endpoints(From the date of implantation until 12 months post-procedure)