Right Ventricular Outflow Tract Stenosis Clinical Trial
Official title:
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
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.
| Status | Recruiting |
| Enrollment | 44 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Venus MedTech (HangZhou) Inc. | Core Medical (Beijing) Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Feasibility and Performance Endpoints | 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. ) |
Day 7 post-implantation | No |
| Other | Secondary Endpoints | 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 |
From the date of valve implantation till 12 months post-procedure | No |
| Primary | 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 | No |
| Secondary | 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 | Yes |