Actively Recruiting
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2023-05-06
500
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
CONDITIONS
Official Title
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years or older
- Aortic valve disease requiring surgery, including severe aortic stenosis with indexed opening area less than 0.5 cm2/m2 and average gradient over 40 mm Hg
- Patients needing coronary artery bypass grafting with moderate aortic stenosis (indexed area 0.5-1 cm2/m2, average gradient over 20 mm Hg), regardless of symptoms
- Patients with symptoms of aortic stenosis regardless of severity
- Mitral valve disease requiring surgical treatment
You will not qualify if you...
- Need for prosthetics of two or more heart valves
- Left ventricular ejection fraction less than 45%
- Presence of other diseases or conditions significantly affecting prognosis, quality of life, or survival
- High pulmonary hypertension with systolic pressure above 60 mm Hg
- Ascending aorta diameter greater than 45 mm
- Unwillingness to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, Russia, 634012
Actively Recruiting
Research Team
E
Ekaterina A/ Kosovskikh
CONTACT
K
Konstantin A. Petlin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here