Short- and Medium-term Results of New Generation Aortic

Cardiac Surgery Clinical Trial

— RVANG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055089
• Other study ID #: PI2021_843_0186
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Joseph NADER, MD
• Phone: 03220735937
• Email: nader.joseph[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve
• Cardiac Surgery
• Echocardiography
• Mortality

Locations

Country	Name	City	State
France	CHU Amiens Nord	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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