Using UniLine Bioprosthesis for Aortic and Mitral Valve Diseases

Open, Prospective, Multicenter Study of the Safety and Efficacy of "UniLine" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases

This study is testing how well the UniLine bioprosthesis works for people with aortic and mitral valve diseases over the long term, including any problems that might come up after the replacement.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Closed Joint-Stock Company NeoCor (Academic / other)
• Locations: 1 site (Kemerovo, Kemerovo Oblast)
• Trial ID: NCT06025149 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with isolated acquired mitral or aortic valve disease who are scheduled for valve replacement using the UniLine bioprosthesis.

Not a fit: Patients with prior heart valve replacements or those requiring urgent interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with isolated aortic and mitral valve diseases.

How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in improving outcomes with bioprosthetic valves, indicating potential for success.

Eligibility criteria

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 this trial is running

Kemerovo, Kemerovo Oblast

• 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

Conditions Aortic Valve Disease; Mitral Valve Disease; UniLine biological prosthesis; Acquired valve disease; Acquired aortic valve disease; Acquired mitral valve disease