RVANG: Short- and Medium-term Results of New Generation Aortic

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05055089

Collaborator

(none)

172

Enrollment

Location

5.9

Anticipated Duration (Months)

28.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Echocardiography Aortic Valve Cardiac Surgery Mortality

Study Design

Study Type:

Observational

Anticipated Enrollment :

172 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
new-generation bioprostheses Patients undergoing surgical aortic valve replacement with new-generation bioprostheses
traditional bioprosthesis patients who received a traditional bioprosthesis

Outcome Measures

Primary Outcome Measures

Variation of mortality rate between both groups [3 months]
both groups are : Patients undergoing surgical aortic valve replacement with new-generation bioprostheses Patients who received a traditional bioprosthesis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.