New biological heart valves with an easy change system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: Elena B. Kim
• Email: ekim@cardio-tomsk.ru

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.