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RECRUITING
NCT05998694

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

Sponsor: Closed Joint-Stock Company NeoCor

View on ClinicalTrials.gov

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.

Official title: Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis "ТiAra" (T-ara)

Key Details

Gender

All

Age Range

60 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2021-06-01

Completion Date

2026-08-10

Last Updated

2024-09-25

Healthy Volunteers

No

Locations (1)

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Kemerovo, Kemerovo Oblast, Russia