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Clinical Trials/NCT05055089
NCT05055089
Recruiting
Not 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 enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Echocardiography
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
172
Locations
1
Primary Endpoint
Variation of mortality rate between both groups
Status
Recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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

Study Sites (1)

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