Severe Aortic Valve Disease Clinical Trial
Official title:
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study
| NCT number | NCT04696926 |
| Other study ID # | CIL 2019-48 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2019 |
| Est. completion date | December 30, 2020 |
| Verified date | January 2021 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study. Methods: All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | September 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Consecutive patients implanted by the Intuity TM bioprosthesis - For severe aortic valve stenosis or severe aortic regurgitation - Including reoperation and combined surgery - Between July 2012 and June 2015 Exclusion Criteria: - absence of patient's authorization for anonymous publication of their clinical data for research purposes |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 5-year overall mortality | overall mortality | 5 years |