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Clinical Trials/NCT05055089
NCT05055089CompletedNot Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country172 target enrollmentStarted: September 6, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
172
Locations
1
Primary Endpoint
Variation of mortality rate between both groups

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Retrospectively included all patients examined since
  • •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.

Arms & Interventions

new-generation bioprostheses

Patients undergoing surgical aortic valve replacement with new-generation bioprostheses

traditional bioprosthesis

patients who received a traditional bioprosthesis

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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