Right Ventricular Outflow Tract Stenosis
Conditions
Keywords
Venus P-valve
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.
Interventions
DEVICEVenus P-valve transcatheter implantation
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Sponsors
Core Medical (Beijing) Co., Ltd.
Venus MedTech (HangZhou) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Performance Endpoints | Day 7 post-implantation | Immediate success of implantation of the device measured in percentage (placement of the device and functional stability measured with angiography and hemodynamic performance). Function normal of the P valve measured in percentage without major adverse events at day 7. (Function normal defined as the P valve's position and function are normal through exams of electrocardiography (EKG), transthoracic echocardiogram (TTE), chest X-ray. ) |
| Secondary Endpoints | From the date of valve implantation till 12 months post-procedure | Changes of images and clinical parameters pre- and post-procedure at 12 months. * CMR: right ventricular volume (expressed as ml/m2), RV ejection fraction (expressed as percentage), pulmonary regurgitation (functional classification as grade I, IIa, IIb and III). * Echo: device position(expressed as percentage), hemodynamic performance of velocity of RVOT and pulmonary valve (expressed as m/s), transvalvular pressure gradient, peak pulmonary valve gradient, mean gradient (expressed as the difference of pressure in mmHg.) * NYHA class |
Countries
China
Contacts
Primary ContactDavid Liu, MD
Outcome results
None listed