Stented Biological Prosthesis Versus Mitral Allograft in Surgical Treatment of Tricuspid Valve Infective Endocarditis.
Mikhail Nuzhdin, Yury Malinovsky, Maksim Galchenko...
https://pubmed.ncbi.nlm.nih.gov/40776959Actively Recruiting
Age: 18Years - 70Years
All Genders
ID06591000
Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
Led by Chelyabinsk Regional Clinical Hospital · Updated on 2024-09-19
56
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the early safety, clinical effectiveness, and long-term outcomes of mitral allografts compared to stented biological prostheses in tricuspid valve replacement for patients with primary tricuspid valve diseases. The study focuses on key outcomes such as survival, freedom from reoperation, repeat endocarditis, and other valve-related complications. Echocardiographic assessments and MSCT scans will also be used to monitor both patient groups. The treatments being studied include mitral allograft implantation and biological stented valve replacement for primary tricuspid valve disease. Patients receive either complete or partial tricuspid valve replacement with a mitral allograft or complete tricuspid valve replacement with a biological prosthesis. These procedures aim to compare the outcomes of these two types of valve replacements. Participants will be monitored for mortality and stroke within 30 days after surgery. Further evaluations of valve function, freedom from prosthetic endocarditis, reoperation, and new pacemaker implantation will occur annually for up to three years. Secondary measures include transvalvular gradient, transprosthetic regurgitation, and right atrial remodeling. This comprehensive follow-up will assess the long-term safety and efficacy of both valve replacement methods.
CONDITIONS
Brief Title
Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
- Intraoperative findings suggesting tricuspid valve replacement rather than repair
- Adults aged between 18 and 70 years
You will not qualify if you...
- Pregnancy
- Confirmed active drug addiction
- Progressive HIV infection
- HIV-infected patients with CD4-cell count less than 250
- Patients with secondary tricuspid valve pathology due to left-sided valve disease
- Left ventricular ejection fraction less than 40 percent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 30 days
Participants undergo tricuspid valve replacement surgery using either a mitral allograft or a biological stented valve.
1 surgery and immediate post-operative period
Post-operative Follow-up
Duration - Up to 3 years
Participants are monitored for valve function, survival, and complications such as stroke, valve dysfunction, and endocarditis.
Annual visits for up to 3 years
Trial Site Locations
Total: 1 location
1
Department of Cardiac Surgery
Chelyabinsk, Russia
Actively Recruiting
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Research Team
M
Mikhail Nuzhdin, PhD
Y
Yuri Malinovsky, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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