Trials / Completed
CompletedNCT01186692
Melody® Transcatheter Pulmonary Valve Post-Approval Study
Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Melody® Transcatheter Pulmonary Valve | Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2013-01-01
- Completion
- 2017-10-01
- First posted
- 2010-08-23
- Last updated
- 2019-05-01
- Results posted
- 2016-12-26
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01186692. Inclusion in this directory is not an endorsement.