Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease

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

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-12

Study Completion Date

2025-09-29

Brief Summary

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The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.

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Detailed Description

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Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation

Conditions

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Bioprosthesis Failure Allograft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stented biological prosthesis

Patients who underwent aortic valve replacement with stented biological valve

aortic valve/root replacement

Intervention Type PROCEDURE

Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft

Allograft aortic root replacement

Patients who underwent allograft aortic root replacement

No interventions assigned to this group

Interventions

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aortic valve/root replacement

Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with degenerative aortic valve disease not emendable for aortic valve repair
* Elective surgery

Exclusion Criteria

* Left ventricle ejection fraction less than 40%
* Redo surgery
* Indication for concomitant mitral valve replacement
* Aortic valve/root endocarditis
* Severe COPD
* Dialysis patients

Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No