Actively Recruiting
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Led by Closed Joint-Stock Company NeoCor · Updated on 2024-09-25
300
Participants Needed
1
Research Sites
856 weeks
Total Duration
On this page
Sponsors
C
Closed Joint-Stock Company NeoCor
Lead Sponsor
R
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases. Main research objectives: To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis. To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data. To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment. To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.
CONDITIONS
Official Title
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent to participate in the study.
- Aged 18 years or older.
- Have isolated acquired mitral or aortic valve disease.
- No prior heart valve replacement; current replacement must be planned (not urgent).
- Planned use of the "UniLine" biological prosthesis made from xenopericardium.
- Able to visit the Research Center.
You will not qualify if you...
- Have mechanical or biological prosthesis in another heart valve position (tricuspid valve repair allowed).
- Prior heart valve replacement.
- Concomitant heart interventions such as coronary artery bypass grafting, coronary heart disease treatment, or left ventricular aneurysm reconstruction.
- History of cancer.
- Severe musculoskeletal or central nervous system disorders causing cognitive impairment or disorientation.
- Acute or subacute infective endocarditis.
- Class IV heart failure with ongoing therapy, left ventricular ejection fraction less than 40%, recent myocardial infarction (less than 90 days), or severe angina.
- Severe somatic, neurological, mental, or infectious diseases worsening long-term survival prognosis, including tuberculosis, HIV, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b, chronic lung diseases requiring corticosteroids and bronchodilators, and multifocal atherosclerosis with significant artery stenosis or prior/planned arterial interventions.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, Russia, 650002
Actively Recruiting
Research Team
E
Evgeny Bazdyrev, MD, PhD
CONTACT
M
Michael Karelin
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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