RecruitingNCT05998694

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

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

Sponsor

Closed Joint-Stock Company NeoCor

Enrollment

2,000 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Disease Artificial Heart Valves

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.

Eligibility

Min Age: 60 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study monitors the long-term safety and function of a biological (tissue-based) heart valve replacement (aortic valve bioprosthesis) in patients who have received this device, to track how well it performs over time. **You may be eligible if...** - You are between 60 and 70 years old with a life expectancy of 3 or more years, OR you are younger than 60 and have medical reasons why you cannot take blood thinners (anticoagulants) - You live in or near the city where the research center is located and can attend follow-up visits - You are able to move around independently and do not have significant cognitive impairment - You have given written consent to participate **You may NOT be eligible if...** - You are unable to travel to the research center for follow-up appointments - You have significant mobility limitations or cognitive disorders preventing you from participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Kemerovo, Kemerovo Oblast, Russia

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NCT05998694

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