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

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.

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Key information

Conditions

Severe Aortic Valve Disease Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards Intuity TM Valve implantation

Other

aortic valve replacement with an Edwards Intuity TM bioprosthesis

Primary outcomes

5-year overall mortality

Time frame: 5 years

overall mortality

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jan 6, 2021
Registry last updated: Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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