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CompletedNCT04696926Updated Jan 6, 2021

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

An observational study in Severe Aortic Valve Disease, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Aortic Valve Disease

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Keywords

  • severe aortic stenosis
  • severe aortic regurgitation
03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 170 is below the median of 200 across 112 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

170 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.

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

Exclusion Criteria:

  • absence of patient's authorization for anonymous publication of their clinical data for research purposes
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • patients who underwent an aortic valve replacement

    Other: Edwards Intuity TM Valve implantation

Interventions

  • OtherEdwards Intuity TM Valve implantation

    aortic valve replacement with an Edwards Intuity TM bioprosthesis

06

What researchers measure

Primary outcomes

  1. 5-year overall mortality

    overall mortality

    Time frame: 5 years

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13005, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04696926
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jan 6, 2021
Start date
Apr 1, 2019
Primary completion
Sep 1, 2020
Completion
Dec 30, 2020
Last update
Jan 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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