Clinical trials: Dysfunctional Right Ventricular Outflow Tract Conduits
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Melody® Transcatheter Pulmonary Valve Post-Approval Study
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
- Trial name
- NCT01186692
- Testing
- Melody® Transcatheter Pulmonary Valve
- Where
- 10 sites in United States
- Volunteers
- 131 people
- Sponsor
- Medtronic Cardiovascular
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