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OpenTrials
Completed

NCT Number: NCT05055089

Short- and Medium-term Results of New Generation Aortic

Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Nord

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Retrospectively included all patients examined since 2010.
  • Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.

Exclusion criteria

  • Refusal to participate in the patient.
  • Patients who have previously had aortic valve surgery.

Treatment and study plan

Primary outcomes

  1. Variation of mortality rate between both groups

    Time frame: 3 months

    both groups are :

    • Patients undergoing surgical aortic valve replacement with new-generation bioprostheses
    • Patients who received a traditional bioprosthesis

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery

Acronym: RVANG

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2021
Registry last updated
Jun 24, 2026

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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