Short- and Medium-term Results of New Generation Aortic

NCT ID: NCT05055089

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Echocardiography Aortic Valve Cardiac Surgery Mortality

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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new-generation bioprostheses

Patients undergoing surgical aortic valve replacement with new-generation bioprostheses

No interventions assigned to this group

traditional bioprosthesis

patients who received a traditional bioprosthesis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Nord

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Joseph NADER, MD

Role: CONTACT

03220735937

Facility Contacts

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Joseph Nader, MD

Role: primary

0322035937

Other Identifiers

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PI2021_843_0186

Identifier Type: -

Identifier Source: org_study_id

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