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The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases

NCT06025149 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-09-25

No results posted yet for this study

Summary

The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases.

Main research objectives:

To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis.

To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data.

To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment.

To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.

Conditions

  • Aortic Valve Disease
  • Mitral Valve Disease

Sponsors & Collaborators

  • Research Institute for Complex Problems of Cardiovascular Diseases, Russia

    collaborator OTHER

  • CT Medical Limited Liability Company

    collaborator UNKNOWN

  • 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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2025-09-09
Completion
2035-01-31

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 NCT06025149 on ClinicalTrials.gov