Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Recruiting · NCT05998694 · Observational (researchers observe without assigning treatment) · Lead sponsor: Closed Joint-Stock Company NeoCor
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
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.
- \* - participation is also possible for those living in the rural areas, but they have to be able to make visits to the Research Center.
- 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\*\*.
- \*\* - Coronary artery bypass grafting, correction of tricuspid valve disease, previously treated congenital heart defects, aortic intervention
- 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.
- The following factors should not be present before surgery: high pulmonary hypertension (pulmonary arterial systolic pressure more than 60 mmHg), functional class 4 (according to the New York Heart Association Functional Classification) while in ongoing treatment, left ventricular ejection fraction less than 30%.
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.
Where it is running
1 location listed.
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia - Kemerovo, Kemerovo Oblast, Russia