Trials / Completed
CompletedNCT02035540
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (actual)
- Sponsor
- corlife · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where * ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval. * The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance. * No additional diagnostic or monitoring procedures shall be applied to the patients * and epidemiological methods shall be used for the analysis of collected data. Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Decellularized human valves |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2014-01-14
- Last updated
- 2022-04-29
Locations
8 sites across 8 countries: Belgium, France, Germany, Italy, Moldova, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02035540. Inclusion in this directory is not an endorsement.