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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Severe Aortic Valve Disease

Treatments: Other: Edwards Intuity TM Valve implantation

Study type: Observational

Funder types: Other

Identifiers

NCT04696926

CIL 2019-48

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 1 patient group

patients who underwent an aortic valve replacement

Treatment:

Other: Edwards Intuity TM Valve implantation