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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allograft tricuspid valve replacement | Patients underwent mitral allograft implantation for primary tricuspid valve disease |
| |
| Stented biological tricuspid valve replacement | Patients underwent biological stented valve replacement for primary tricuspid valve disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tricuspid valve replacement | Procedure | Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Freedom from all-cause mortality (%) | 30-day period after surgery |
| Stroke | Stroke rate (n,%) | 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,%) | 1-year after surgery, annually, assessed up to 3 years |
| Freedom from prosthetic endocarditis | Number of patients free from prosthetic endocarditis (n,%) | 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,%) | 1-year after surgery, annually, assessed up to 3 years |
| New pacemaker implantation | Number of patients, free from pacemaker implantation after surgery (n,%) | 1-year after surgery, annually, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Transvalvular gradient | Peak and mean gradient (mmHg) | 1 year after surgery, annually, assessed up to 3 years |
| Transprosthetic regurgitation | Vena contracta (mm) |
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Inclusion Criteria:
Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
Exclusion Criteria:
Pregnancy
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Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Nuzhdin, PhD | Contact | 0079068608612 | austesla2022@gmail.com | |
| Yuri Malinovsky, PhD | Contact | 0073517493732 | mikhailnuzhdin@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuri Malinovsky, PhD | Department of Cardiac Surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac Surgery | Recruiting | Chelyabinsk | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40776959 | Derived | 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. |
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| 1 year after surgery, annually, assessed up to 3 years |
| Right atrial remodeling | right atrium size (mm) | 1 year after surgery, annually, assessed up to 3 years |