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

Study acronym: TiAra
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated September 25, 2024 (before its estimated August 10, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Aug 10, 2024 to Aug 10, 2025
    • Study completion date: Aug 10, 2024 to Aug 10, 2026
    v3
  3. Primary endpoints revised (2)
    • Site contact updated
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05998694
Lead Sponsor Closed Joint-Stock Company NeoCor
Collaborators: CT Medical Limited Liability Company, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Conditions
(from sponsor)		 Aortic Valve Disease, Artificial Heart Valves
Related terms Anemia, Hemolytic, Aortic Valve Disease, Arrhythmias, Cardiac, Heart Failure, Hemolysis, Hemorrhage, Joint Dislocations, Myocardial Infarction, Thromboembolism
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov