Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis (NCT05998694) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Russia2,000 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range
60 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. The patient is a resident of the city\* (suburb) where the institution is conducting study.
. 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.
. Isolated aortic valve disease.
. Real intervention on the heart valve is primary.
. Absence of concomitant interventions on the heart and thoracic aorta\*\*.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the long term (long-term safety and durability)
Timeframe: Up to 12 years from the moment of implantation .
2
2. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the short term (short-term safety)
Timeframe: Up to 12 years from the moment of implantation
. The intervention on the valve is planned (that is, it is not carried out in expedited/urgent manner or is not a "rescue" operation).
. Absence of acute and subacute infective endocarditis.
Exclusion criteria
. The presence of severe somatic, neurological, mental diseases and infectious diseases that worsen the prognosis of long-term survival (ischemic heart disease, tuberculosis, human immunodeficiency viruses, Alzheimer's disease, epilepsy, insulin-requiring diabetes, kidney disease with creatinine clearance less than 85 mL/min, chronic lung disease requiring chronic corticosteroids and bronchodilators, multifocal atherosclerosis (intermittent claudication, carotid arteries stenosis of more than 50%, prior and planned interventions on abdominal area, carotid arteries or arteries of the lower extremities).
. The patient has any not related to the underlying cardiovascular system disease pathology that will lead to the death of the patient in less than 1 year.
. The patient is currently participating in a study of a new drug or other medical devices.