Evaluating the safety and effectiveness of the TiAra aortic valve bioprosthesis

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

This study is testing how safe and effective the TiAra aortic valve is for people who need an aortic valve replacement, looking at their health and quality of life over the next 10 years.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 60 Years to 70 Years
• Sex: All
• Sponsor: Closed Joint-Stock Company NeoCor (Academic / other)
• Locations: 1 site (Kemerovo, Kemerovo Oblast)
• Trial ID: NCT05998694 on ClinicalTrials.gov

What this trial studies

This multicenter prospective cohort study aims to assess the long-term safety and efficacy of the TiAra aortic valve bioprosthesis in patients undergoing aortic valve replacement. The study will analyze clinical outcomes over a period of up to 10 years, focusing on hemodynamic characteristics and complications associated with the prosthesis. Participants will be monitored for short and mid-term outcomes, with a particular emphasis on the integration of the valve into the native aortic root and its impact on heart function and quality of life.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60-70 with isolated aortic valve disease or younger patients with contraindications to anticoagulants who choose a biological prosthesis.

Not a fit: Patients with significant comorbidities affecting physical movement or those requiring concomitant heart interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with aortic valve disease, enhancing heart function and quality of life.

How similar studies have performed: While this approach is novel in its specific application, similar studies evaluating bioprosthetic valves have shown promising results in terms of safety and efficacy.

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 grafting, correction of tricuspid valve disease, previously treated congenital heart defects, aortic intervention
7. The intervention on the valve is planned (that is, it is not carried out in expedited/urgent manner or is not a "rescue" operation).
8. Absence of acute and subacute infective endocarditis.
9. 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:

1. 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).
2. 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.
3. The patient is currently participating in a study of a new drug or other medical devices.

Where this trial is running

Kemerovo, Kemerovo Oblast

• Research Institute for Complex Problems of Cardiovascular Diseases, Russia — Kemerovo, Kemerovo Oblast, Russia (Recruiting)

Study contacts

• Principal investigator: Alexey Evtushenko, MD,PhD — Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Study coordinator: Alexey Evtushenko, MD,PhD

Conditions Aortic Valve Disease; Artificial Heart Valves; aortic valve; aortic valve bioprothesis TiAra; valve bioprosthesis; hemolysis; hemolytic anemia; a heart stroke