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

NCT05895487 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-09-26

No results posted yet for this study

Summary

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.

Conditions

  • 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

Sponsors & Collaborators

  • CT Medical Limited Liability Company

    collaborator UNKNOWN

  • Research Institute for Complex Problems of Cardiovascular Diseases, Russia

    collaborator OTHER

  • Closed Joint-Stock Company NeoCor

    lead OTHER

Principal Investigators

  • Alexander Bogachev-Prokofiev, MD, PhD · National Medical Research Center named after Academician E.N. Meshalkin

  • Alexey Evtushenko, MD, PhD · Research Institute for Complex Issues of Cardiovascular Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-10-01
Completion
2026-05-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05895487 on ClinicalTrials.gov