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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04696926

Enrollment

170

Registered

2021-01-06

Start date

2019-04-01

Completion date

2020-12-30

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Aortic Valve Disease

Keywords

severe aortic stenosis, severe aortic regurgitation

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.

Interventions

OTHEREdwards Intuity TM Valve implantation

aortic valve replacement with an Edwards Intuity TM bioprosthesis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
5-year overall mortality	5 years	overall mortality

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026