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Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis

NCT05998694 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-09-25

No results posted yet for this study

Summary

The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures.

Main research objectives:

1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis.
2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation.
3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis.

This study does not presuppose implementation of comparison groups.

Conditions

  • Aortic Valve Disease
  • Artificial Heart Valves

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

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

Eligibility

Min Age
60 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-08-10
Completion
2026-08-10

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 NCT05998694 on ClinicalTrials.gov