Short- and Medium-term Results of New Generation Aortic

Recruiting

• Conditions: Cardiac Surgery; Mortality; Echocardiography; Aortic Valve

• Registration Number: NCT05055089
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Amiens Nord; 🇫🇷 Amiens, France