Right Ventricular Outflow Tract Dysfunction
Conditions
Brief summary
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Detailed description
All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required. Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.
Interventions
A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.
Sponsors
IQVIA MedTech BV of Antwerp, Belgium
MDCECRO LLC
Venus MedTech (HangZhou) Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention. 2. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.
Exclusion criteria
1\. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-hierarchical composite endpoint | at six months | * Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | at 30 days | Procedure success at 30 days, defined as: * Freedom from procedure/device-related mortality * Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device * Acceptable hemodynamic function * Original intended valve in situ |
| Occurrence of Events | through five years | Occurrence of the following events through 5 years of follow-up: * All-cause mortality and procedure/device-related mortality * Venus P-ValveTM (catheter or surgical) reintervention * Venus P-ValveTM dysfunction * Serious procedure/device-related adverse events |
| Functional status | through five years | New York Heart Association (NYHA) classification out to 5 years |
| Health-state utility score | through five years | Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years. |
Countries
France, Germany, Italy, United Kingdom
Contacts
Primary ContactCong Ma
Backup ContactPing Zhang
Outcome results
None listed