NCT05998694 Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
| NCT ID | NCT05998694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Closed Joint-Stock Company NeoCor |
| Condition | Aortic Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-08-10 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: 1. The patient's written consent to participate in the study and the absence of restrictions on physical movement (diseases of the musculoskeletal system and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination). 2. The patient is a resident of the city\* (suburb) where the institution is conducting study. \* - participation is also possible for those living in the rural areas, but they have to be able to make visits to the Research Center. 3. Age: 60-70 years old with a life expectancy of 3 years or more. Or a person younger than 60 with contraindications to taking anticoagulants, or with increased risk of their use, consciously choosing a biological prosthesis for valve replacement. 4. Isolated aortic valve disease. 5. Real intervention on the heart valve is primary. 6. Absence of concomitant interventions on the heart and thoracic aorta\*\*. \*\* - Coronary artery bypass graft