Actively Recruiting
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Led by Closed Joint-Stock Company NeoCor · Updated on 2024-09-25
2000
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
C
Closed Joint-Stock Company NeoCor
Lead Sponsor
C
CT Medical Limited Liability Company
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient's written consent to participate and absence of physical movement restrictions due to musculoskeletal or cognitive disorders
- Resident of the city or suburb where the study center is located, able to visit the research center
- Age between 60 and 70 years with life expectancy of at least 3 years, or younger than 60 with contraindications or high risk for anticoagulant use choosing a biological prosthesis
- Isolated aortic valve disease
- Planned primary heart valve intervention
- No additional heart or thoracic aorta surgeries planned (such as coronary bypass or tricuspid valve correction)
- Intervention is planned, not urgent or rescue
- No acute or subacute infective endocarditis
- No high pulmonary hypertension (pulmonary arterial systolic pressure over 60 mmHg), no functional class 4 heart failure under treatment, and left ventricular ejection fraction at least 30%
You will not qualify if you...
- Severe somatic, neurological, mental or infectious diseases worsening long-term survival (including ischemic heart disease, tuberculosis, HIV, Alzheimer's, epilepsy, insulin-dependent diabetes, kidney disease with creatinine clearance below 85 mL/min, chronic lung disease requiring corticosteroids, multifocal atherosclerosis)
- Any non-cardiovascular disease expected to cause death within one year
- Current participation in another clinical trial involving drugs or medical devices
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, Russia, 650002
Actively Recruiting
Research Team
A
Alexey Evtushenko, MD,PhD
CONTACT
D
Denis Lebedev, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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