Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Right Ventricular Outflow Tract Stenosis

Intervention / Treatment
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* Device: Venus P-valve transcatheter implantation


Participation Criteria
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Eligibility Criteria
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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 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venus P-valve transcatheter implantation<br>Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis | Device: Venus P-valve transcatheter implantation<br>* Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of RVEDV at 6 months post-procedure. | The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR. | At 6 months post-implantation of Venus-P valve | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints | 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. | From the date of implantation until 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venus P-valve