Trials / Completed
CompletedNCT01356108
Pulmonic Valve REplacement Multi-discIpline EMEA Registry
Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 127 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.
Detailed description
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV) | The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-07-01
- Completion
- 2017-12-19
- First posted
- 2011-05-19
- Last updated
- 2018-11-20
Locations
16 sites across 9 countries: Belgium, Germany, Ireland, Israel, Italy, Poland, Saudi Arabia, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01356108. Inclusion in this directory is not an endorsement.