NCT05895487

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

Recruiting now Last updated 26 September 2024

What this trial tests

trial in Diseases of Mitral and Aortic Valves in 2,000 participants. Currently enrolling.

Timeline

1 November 2022

Primary endpoint
1 October 2025

1 May 2026

Quick facts

Lead sponsor	Closed Joint-Stock Company NeoCor
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	1 November 2022
Primary completion	1 October 2025
Estimated completion	1 May 2026
Sites	1 location across Russia

Conditions studied

• Diseases of Mitral and Aortic Valves — all drugs for Diseases of Mitral and Aortic Valves →
• Rheumatic Disorders of Mitral and Aortic Valves — all drugs for Rheumatic Disorders of Mitral and Aortic Valves →
• Other Congenital Malformations of Aortic and Mitral Valves — all drugs for Other Congenital Malformations of Aortic and Mitral Valves →
• Valvular Heart Disease (Aortic and Mitral Valves) — all drugs for Valvular Heart Disease (Aortic and Mitral Valves) →

Sponsor

Closed Joint-Stock Company NeoCor

Who can join

18 and older, any sex, with Diseases of Mitral and Aortic Valves or Rheumatic Disorders of Mitral and Aortic Valves. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.