← Back to all trials
Recruiting
NCT04442100
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Conditions: Heart Valve Diseases
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 500
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Location: Tomsk National Research Medical Center of the Russian Academy of Sciences Tomsk Tomsk Oblast
Summary
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
Eligibility Criteria
Inclusion Criteria:
1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;
o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)
2. mitral valve disease requiring surgical disease
Exclusion Criteria:
1. the need for prosthetics of two or more valves
2. patients with a decrease in LVEF of less than 45%;
3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
5. the diameter of the ascending aorta is more than 45 mm;
6. unwillingness of the patient to participate in the study.
Source: ClinicalTrials.gov (NCT04442100). StuddyBuddy aggregates publicly available trial information.