Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

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

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-14

Study Completion Date

2025-06-14

Brief Summary

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The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.

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Detailed Description

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Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Conditions

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Allograft Bioprosthesis Tricuspid Valve Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Allograft tricuspid valve replacement

Patients underwent mitral allograft implantation for primary tricuspid valve disease

tricuspid valve replacement

Intervention Type PROCEDURE

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Stented biological tricuspid valve replacement

Patients underwent biological stented valve replacement for primary tricuspid valve disease

tricuspid valve replacement

Intervention Type PROCEDURE

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Interventions

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tricuspid valve replacement

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.

* Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria

* Pregnancy

* Confirmed active drug addiction
* Progressive HIV-infection
* HIV-infected patients with CD4-cells count less than 250
* Patients with secondary tricuspid valve pathology (left-sided valve disease)
* LV Ejection fraction less than 40%

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No