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

Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06591000

Enrollment

Registered

2024-09-19

Start date

2016-01-14

Completion date

2025-06-14

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft, Bioprosthesis, Tricuspid Valve Disease

Brief summary

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

PROCEDUREtricuspid valve replacement

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

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame	Description
New pacemaker implantation	1-year after surgery, annually, assessed up to 3 years	Number of patients, free from pacemaker implantation after surgery (n,%)
Severe valve dysfunction	1-year after surgery, annually, assessed up to 3 years	Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)
Freedom from prosthetic endocarditis	1-year after surgery, annually, assessed up to 3 years	Number of patients free from prosthetic endocarditis (n,%)
Freedom from reoperation	1-year after surgery, annually, assessed up to 3 years	Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)
Mortality	30-day period after surgery	Freedom from all-cause mortality (%)
Stroke	30-day period after surgery	Stroke rate (n,%)

Secondary

Measure	Time frame	Description
Transprosthetic regurgitation	1 year after surgery, annually, assessed up to 3 years	Vena contracta (mm)
Right atrial remodeling	1 year after surgery, annually, assessed up to 3 years	right atrium size (mm)
Transvalvular gradient	1 year after surgery, annually, assessed up to 3 years	Peak and mean gradient (mmHg)

Countries

Russia

Contacts

Primary ContactMikhail Nuzhdin, PhD

austesla2022@gmail.com0079068608612

Backup ContactYuri Malinovsky, PhD

mikhailnuzhdin@hotmail.com0073517493732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026