- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696926
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13005
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients who underwent an aortic valve replacement
|
aortic valve replacement with an Edwards Intuity TM bioprosthesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year overall mortality
Time Frame: 5 years
|
overall mortality
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIL 2019-48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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