Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve

Completed

• Conditions: Severe Aortic Valve Disease
• Interventions: Other: Edwards Intuity TM Valve implantation

• Registration Number: NCT04696926
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who underwent an aortic valve replacement	Edwards Intuity TM Valve implantation	-

Primary Outcome Measures

Name	Time	Method
5-year overall mortality	5 years	overall mortality

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France