Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tricuspid valve replacement.
- Who it may be relevant to
- Registry conditions: Allograft, Bioprosthesis, Tricuspid Valve Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
Overview
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.
Detailed description
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.
Interventions
- Procedure tricuspid valve replacement
Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis
Primary outcome measures
- Mortality [Time frame: 30-day period after surgery]
- Stroke [Time frame: 30-day period after surgery]
- Severe valve dysfunction [Time frame: 1-year after surgery, annually, assessed up to 3 years]
- Freedom from prosthetic endocarditis [Time frame: 1-year after surgery, annually, assessed up to 3 years]
- Freedom from reoperation [Time frame: 1-year after surgery, annually, assessed up to 3 years]
- New pacemaker implantation [Time frame: 1-year after surgery, annually, assessed up to 3 years]
Secondary outcome measures (3)
- Transvalvular gradient [Time frame: 1 year after surgery, annually, assessed up to 3 years]
- Transprosthetic regurgitation [Time frame: 1 year after surgery, annually, assessed up to 3 years]
- Right atrial remodeling [Time frame: 1 year after surgery, annually, assessed up to 3 years]
Eligibility criteria
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Russia · 1 center
- Department of Cardiac Surgery — Chelyabinsk
Publications
- Nuzhdin M, Malinovsky Y, Galchenko M, Komarov R, Fokin A, Nadtochiy N. Stented Biological Prosthesis Versus Mitral Allograft in Surgical Treatment of Tricuspid Valve Infective Endocarditis. Rev Cardiovasc Med. 2025 Jul 8;26(7):37204. doi: 10.31083/RCM37204. eCollection 2025 Jul. PMID 40776959
Identifiers
NCT: NCT06591000 · 14012016