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

Recruiting

• Conditions: Allograft; Bioprosthesis; Tricuspid Valve Disease
• Interventions: Procedure: tricuspid valve replacement

• Registration Number: NCT06591000
• Lead Sponsor: Chelyabinsk Regional Clinical Hospital

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.

Study Timeline

• Study Start: 2016-01-14
• Study First Submitted: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2024-12-14
• Study Completion: 2025-06-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allograft tricuspid valve replacement	tricuspid valve replacement	Patients underwent mitral allograft implantation for primary tricuspid valve disease
Stented biological tricuspid valve replacement	tricuspid valve replacement	Patients underwent biological stented valve replacement for primary tricuspid valve disease

Primary Outcome Measures

Name	Time	Method
Mortality	30-day period after surgery	Freedom from all-cause mortality (%)
Stroke	30-day period after surgery	Stroke rate (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,%)
New pacemaker implantation	1-year after surgery, annually, assessed up to 3 years	Number of patients, free from pacemaker implantation after surgery (n,%)

Secondary Outcome Measures

Name	Time	Method
Transvalvular gradient	1 year after surgery, annually, assessed up to 3 years	Peak and mean gradient (mmHg)
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)

Trial Locations

Locations (1)

Department of Cardiac Surgery; 🇷🇺 Chelyabinsk, Russian Federation