Trials / Completed
CompletedNCT02347189
Melody PB1016 Surveillance Study
Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Medtronic Heart Valves · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Melody Transcatheter Pulmonary Valve PB1016 |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-11-01
- Completion
- 2018-08-10
- First posted
- 2015-01-27
- Last updated
- 2019-11-06
- Results posted
- 2017-11-29
Locations
8 sites across 4 countries: United States, Austria, Canada, Spain
Source: ClinicalTrials.gov record NCT02347189. Inclusion in this directory is not an endorsement.