Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

Recruiting now

Conditions studied: Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves, Other Congenital Malformations of Aortic and Mitral Valves, Valvular Heart Disease (Aortic and Mitral Valves), Mitral Valve Insufficiency and Aortic Valve Insufficiency

In brief

Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than 40 regions by specialists from 92 healthcare organizations. Treating aortic or mitral valve disease using the "UniLine" biological prosthesis is expected to improve survival rates. Supposedly, in vivo the "UniLine" biological prosthesis will show optimal hemodynamic characteristics and high resistance to structural valve degeneration and infectious damage, thus lowering the risk of dysfunction. Moreover, the risk of repeated intervention due to dysfunction of the "UniLine" bioprosthesis should not exceed the risk of the primary implantation. Supposedly, in the case of dysfunction of "UniLine" bioprosthesis it would be possible to perform repeated replacement using valve-in-valve technique. The aim of the study is to assess the effectiveness, safety, durability of the "UniLine" epoxy-treated prosthesis and the long-term outcome of the treatment of isolated mitral and aortic valve diseases using this prosthesis. In accordance with the objectives and hypothesis, the following data will be analyzed: actuarial and linear survival rates (general and cardiac), non-lethal prosthesis-associated complications, prosthetic dysfunction and repeated interventions. Moreover, in vivo hemodynamic parameters of the prosthesis will be assessed: the area of the effective opening surface, peak and mean gradient of pressure and blood flow velocity. The study will be conducted at the Research Institute of Complex Issues of Cardiovascular Diseases. Study protocol received sponsorship approval and approval by Local Ethics Committee of the Research Institute and Research Coordinating Committee. The study will enroll patients who underwent isolated mitral or aortic valve replacement; transthoracic echocardiography will be conducted in all patients available for in-person visit.

Key facts

Study ID

NCT05895487

Run by

Closed Joint-Stock Company NeoCor

People needed

2000

Starts

2022-11-01

Expected to finish

2026-05-01

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases" — Kemerovo, Russia (enrolling)

Full record on ClinicalTrials.gov

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