Trials / Completed
CompletedNCT02023775
Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 409 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.
Detailed description
This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Melody valve implantation |
Timeline
- Start date
- 2010-01-31
- Primary completion
- 2013-01-24
- Completion
- 2013-10-20
- First posted
- 2013-12-30
- Last updated
- 2025-07-03
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02023775. Inclusion in this directory is not an endorsement.