New biological heart valves with an easy change system
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
NA · Tomsk National Research Medical Center of the Russian Academy of Sciences · NCT04442100
This study is testing new biological heart valves that are easier to replace to see how well they work and how they affect patients' health and quality of life after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences (other) |
| Locations | 1 site (Tomsk, Tomsk Oblast) |
| Trial ID | NCT04442100 on ClinicalTrials.gov |
What this trial studies
This study evaluates new biological heart valves designed with an 'easy change' system, focusing on their hemodynamic characteristics, complications from implantation, and overall mortality rates. It employs transesophageal ultrasound to assess various cardiac strains and utilizes the SF36 questionnaire to evaluate patient quality of life. Additionally, the study examines the effectiveness of antithrombotic therapy post-implantation and assesses heart failure through a six-minute walking test and plasma BNP levels.
Who should consider this trial
Good fit: Ideal candidates include patients with severe aortic stenosis or mitral valve disease requiring surgical intervention.
Not a fit: Patients needing multiple valve prosthetics or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved outcomes and quality of life for patients with heart valve diseases.
How similar studies have performed: While similar approaches have been explored, this specific 'easy change' system is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tomsk, Tomsk Oblast
- Tomsk National Research Medical Center of the Russian Academy of Sciences — Tomsk, Tomsk Oblast, Russia (RECRUITING)
Study contacts
- Principal investigator: Boris N. Kozlov, MD — Tomsk National Research Medical Center of the Russian Academy of Sciences
- Study coordinator: Ekaterina A/ Kosovskikh
- Email: katekorovina93@gmail.com
- Phone: +79528912091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Valve Diseases