Evaluating the UniLine Prosthesis for Aortic and Mitral Valve Diseases
Multicentered Observational Cohort Study on the Efficacy, Safety and Durability of the "UniLine" Epoxy-treated Prosthesis Made With Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Disease (UniLine RetroFit)
This study is testing a new heart valve replacement called the UniLine prosthesis to see if it helps people with aortic and mitral valve diseases live better and longer after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Closed Joint-Stock Company NeoCor Academic / other |
| Locations | 1 site (Kemerovo) |
| Trial ID | NCT05895487 on ClinicalTrials.gov |
What this trial studies
This study assesses the efficacy, safety, and durability of the UniLine biological prosthesis in treating aortic and mitral valve diseases. It aims to improve survival rates and reduce the risk of dysfunction associated with these prosthetic valves. The study involves patients who have undergone isolated valve replacement surgery using the UniLine prosthesis, focusing on their postoperative outcomes and quality of life. The research is conducted across multiple healthcare organizations in Russia, where heart valve diseases are a significant health concern.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who have undergone isolated mitral or aortic valve replacement with the UniLine bioprosthesis.
Not a fit: Patients with prior heart valve replacements or those with active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with aortic and mitral valve diseases.
How similar studies have performed: Other studies have shown success with bioprosthetic valves, suggesting that this approach may yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes aged 18 years and older who underwent isolated mitral or aortic valve replacement using the "UniLine" bioprosthesis * No prior heart valve replacement Exclusion Criteria: * The presence of a mechanical or biological prosthesis in another position * Prior valve repair * Aortic aneurysm repair (ascending aorta) * Resection of a left ventricular aneurysm * Patients with active cancer and patients with history of cancer
Where this trial is running
Kemerovo
- Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases" — Kemerovo, 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
- Email: clinicresearch@kemcardio.ru
- Phone: +7 (3842) 644240
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.