An observational study in Allograft, Bioprosthesis and Tricuspid Valve Disease, sponsored by Chelyabinsk Regional Clinical Hospital. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Chelyabinsk Regional Clinical Hospital · Observational
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.
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.
Chelyabinsk Regional Clinical Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
Exclusion Criteria:
Pregnancy
Patients underwent mitral allograft implantation for primary tricuspid valve disease
Procedure: tricuspid valve replacement
Patients underwent biological stented valve replacement for primary tricuspid valve disease
Procedure: tricuspid valve replacement
Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis
Mortality
Freedom from all-cause mortality (%)
Time frame: 30-day period after surgery
Stroke
Stroke rate (n,%)
Time frame: 30-day period after surgery
Severe valve dysfunction
Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)
Time frame: 1-year after surgery, annually, assessed up to 3 years
Freedom from prosthetic endocarditis
Number of patients free from prosthetic endocarditis (n,%)
Time frame: 1-year after surgery, annually, assessed up to 3 years
Freedom from reoperation
Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)
Time frame: 1-year after surgery, annually, assessed up to 3 years
New pacemaker implantation
Number of patients, free from pacemaker implantation after surgery (n,%)
Time frame: 1-year after surgery, annually, assessed up to 3 years
Transvalvular gradient
Peak and mean gradient (mmHg)
Time frame: 1 year after surgery, annually, assessed up to 3 years
Transprosthetic regurgitation
Vena contracta (mm)
Time frame: 1 year after surgery, annually, assessed up to 3 years
Right atrial remodeling
right atrium size (mm)
Time frame: 1 year after surgery, annually, assessed up to 3 years
Plan to share: Undecided
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Chelyabinsk Regional Clinical Hospital