Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Core Medical (Beijing) Co., Ltd. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venus P-valve transcatheter implantation | Experimental | Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venus P-valve transcatheter implantation | Device | Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. ) |
Inclusion Criteria:
Add any of the following conditions:
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are present:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Liu, MD | Contact | +86 10 6595 6828 | 806 | davidliu@coremed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, Prof., MD. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From the date of implantation until 12 months post-procedure |
| Day 7 post-implantation |
| Secondary Endpoints | Changes of images and clinical parameters pre- and post-procedure at 12 months.
| From the date of valve implantation till 12 months post-procedure |