Clinical trials: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Melody PB1016 Surveillance Study
Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
- Trial name
- NCT02347189
- Testing
- Melody Transcatheter Pulmonary Valve PB1016
- Where
- 8 sites in United States, Austria and 2 more
- Volunteers
- 39 people
- Sponsor
- Medtronic Heart Valves