Clinical trial NCT06591000: Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
Official title: Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allograft
Bioprosthesis
Tricuspid Valve Disease
Lead sponsor: Chelyabinsk Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention

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.

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%

Primary outcomes:
measure: Mortality
timeFrame: 30-day period after surgery
measure: Stroke
timeFrame: 30-day period after surgery
measure: Severe valve dysfunction
timeFrame: 1-year after surgery, annually, assessed up to 3 years
measure: Freedom from prosthetic endocarditis
timeFrame: 1-year after surgery, annually, assessed up to 3 years
measure: Freedom from reoperation
timeFrame: 1-year after surgery, annually, assessed up to 3 years
measure: New pacemaker implantation
timeFrame: 1-year after surgery, annually, assessed up to 3 years
Secondary outcomes:
measure: Transvalvular gradient
timeFrame: 1 year after surgery, annually, assessed up to 3 years
measure: Transprosthetic regurgitation
timeFrame: 1 year after surgery, annually, assessed up to 3 years
measure: Right atrial remodeling
timeFrame: 1 year after surgery, annually, assessed up to 3 years
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Department of Cardiac Surgery
Study officials:
affiliation: Department of Cardiac Surgery
name: Yuri Malinovsky, PhD
role: STUDY_CHAIR
References: