Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allograft
- Sponsor
- Chelyabinsk Regional Clinical Hospital
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Freedom from prosthetic endocarditis
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Mikhail Nuzhdin
Director
Chelyabinsk Regional Clinical Hospital
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%
Outcomes
Primary Outcomes
Freedom from prosthetic endocarditis
Time Frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from prosthetic endocarditis (n,%)
Mortality
Time Frame: 30-day period after surgery
Freedom from all-cause mortality (%)
Stroke
Time Frame: 30-day period after surgery
Stroke rate (n,%)
Freedom from reoperation
Time Frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)
Severe valve dysfunction
Time Frame: 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,%)
New pacemaker implantation
Time Frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients, free from pacemaker implantation after surgery (n,%)
Secondary Outcomes
- Transvalvular gradient(1 year after surgery, annually, assessed up to 3 years)
- Transprosthetic regurgitation(1 year after surgery, annually, assessed up to 3 years)
- Right atrial remodeling(1 year after surgery, annually, assessed up to 3 years)