Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

N/AActive Not RecruitingNCT06196684

Chelyabinsk Regional Clinical Hospital30 enrolled

Overview

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Allografts Tricuspid Valve Insufficiency

Interventions

Mitral allograft implantationPROCEDURE

Tricuspid valve replacement with mitral valve allograft

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 50%

Locations (1)

Department of Cardiac Surgery

Chelyabinsk, Chelyabinsk Oblast, Russia

Outcomes

Primary Outcomes

Mortality (all cause and valve-related)

Estimate rate of mortality (all cause and valve-related)

Time frame: 30-day period

Secondary Outcomes

Neurologic events

any neurological events in 30-day period

Time frame: 30-day period

Bleeding and transfusions

Freedom from major bleeding events

Time frame: 30 days

Cardiac structural complications

any structural cardiac complication

Time frame: 30 days

Acute kidney injury

freedom from type 3-4 AKI

Time frame: 30 days

Allograft valve dysfunction

freedom from allograft valve stenosis or regurgitation

Time frame: 30 days

Data from ClinicalTrials.gov

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