Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
- Conditions
- Right Ventricular Outflow Tract Stenosis
- Interventions
- Device: Venus P-valve transcatheter implantation
- Registration Number
- NCT02071654
- Lead Sponsor
- Venus MedTech (HangZhou) Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- 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
- Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
- ≥3+ pulmonary regurgitation by echocardiograms
- Deteriorating RVEF%
- Progressive tricuspid valve regurgitation (at least moderate degree)
- Complicated with RVOT obstruction (RV systolic pressure>80mmHg)
- Persistent arrhythmias
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
- ADHF
- 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
- Ileofemoral vessel characteristics that would preclude safe placement of introducer sheath
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Venus P-valve transcatheter implantation Venus P-valve transcatheter implantation Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
- Primary Outcome Measures
Name Time Method Improvement rate of RVEDV at 6 months post-procedure. At 6 months post-implantation of Venus-P valve The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
- Secondary Outcome Measures
Name Time Method Safety Endpoints From the date of implantation until 12 months post-procedure Accumulated occurrences (rate of patients/year) of procedure-related clinical events (death, severe arrhythmias, cardiac tamponade, RVOT or pulmonary artery perforation or rupture, cardiac shock, endocarditis from the date of valve implantation up to 12 months post-procedure or bleeding due to use of heparin/aspirin at 48 hours post-procedure assessed per protocol.
Occurrence of all deaths (cardiac death, non-cardiac deaths and other deaths) and stroke one year post-procedure.
Trial Locations
- Locations (1)
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China