Using UniLine Bioprosthesis for Aortic and Mitral Valve Diseases

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 observational study aims to evaluate the long-term outcomes of aortic and mitral valve replacement using the UniLine bioprosthesis in patients with acquired valve diseases. It will analyze hemodynamic characteristics through transthoracic echocardiography and assess the frequency and types of dysfunctions associated with the prosthesis. The study will also monitor major adverse events related to the procedure over a period of up to 12 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provided informed consent to participate in the study.
2. Must be aged 18 years and older.
3. Patients with isolated acquired mitral or aortic valve disease.
4. No prior heart valve replacement, current replacement must be planned (not conducted in an urgent/ emergency manner), using the "UniLine" biological prosthesis made from xenopericardium.
5. Patient must be able to visit the Research Center.

Exclusion Criteria:

1. Mechanical or biological prosthesis in another position. Patients with tricuspid valve repair may be included in the study.
2. Prior heart valve replacement.
3. Concomitant interventions on the heart (coronary artery bypass grafting, coronary heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and thoracic aorta.
4. Patients with cancer in history.
5. Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).
6. Acute or subacute stages of infective endocarditis.
7. Class IV heart failure according to the New York Heart Association Functional Classification with ongoing therapy, left ventricular ejection fraction less than 40%, myocardial infarction less than 90 days old, angina pectoris grade 4.
8. The presence of severe somatic, neurological, mental and infectious diseases that worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular Filtration Rate less than 30 mL/ min / 1.73 m²), chronic lung diseases requiring constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%, prior and planned interventions on the abdominal aorta, carotid arteries or arteries of the lower extremities).

Where it's running

• Research Institute for Complex Problems of Cardiovascular Diseases, Russia
  Kemerovo, Kemerovo Oblast, Russia Recruiting

Study contacts

• Principal investigator: Alexander Bogachev-Prokofiev, MD, PhD — National Medical Research Center named after Academician E.N. Meshalkin
• Study coordinator: Evgeny Bazdyrev, MD, PhD
• Email: clinicresearch@kemcardio.ru
• Phone: +7-3842-64-42-40

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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.