Short- and Medium-term Results of New Generation Aortic

NCT05055089 | Unknown

• 1 other identifier: PI2021_843_0186
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography; Aortic Valve; Cardiac Surgery; Mortality

Keywords

Echocardiography; Aortic valve; New-generation bioprosthesis; Conventional bioprosthesis; Rapid-deployment bioprosthesis; Sutureless valves; Function prostheses; Cardiac Surgery; Mortality

Outcome Measures

Primary Outcomes (1)

• Variation of mortality rate between both groups

  both groups are : * Patients undergoing surgical aortic valve replacement with new-generation bioprostheses * Patients who received a traditional bioprosthesis

  3 months

Study Arms (2)

new-generation bioprostheses

Patients undergoing surgical aortic valve replacement with new-generation bioprostheses

traditional bioprosthesis

patients who received a traditional bioprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Cardiac Surgery Department of the University Hospital of Amiens of Picardy, France, short- and medium-term survival of patients undergoing surgical aortic valve replacement with new-generation bioprostheses compared with patients who received a traditional bioprosthesis.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Nord

Amiens, 80054, France

RECRUITING

Central Study Contacts

Joseph NADER, MD

CONTACT

03220735937; nader.joseph@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)