Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
Conditions
Interventions
Intervention1: Transcatheter Aortic Valve Implantation (TAVI): Transcatheter Aortic Valve Implantation will be performed by using Model 3 Transcatheter Heart Valve (Myval Inception)
The study duratio
Sponsors
Meril Diagnostics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 2. Patient or their legally acceptable representative (LAR) has provided written informed consent as approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of the investigational site to participate in the study. 3. Patients with symptomatic/asymptomatic severe native aortic stenosis or patients with moderate native aortic stenosis. Severe aortic stenosis is defined as mean gradient >=40 mmHg, peak velocity >=4.0 m/s, valve area cm2 /m2) [3] Asymptomatic patients with LVEF OR exercise test resulting in symptoms OR sustained fall in blood pressure ( >20 mmHg) below baseline during exercise testing
Exclusion criteria
Exclusion criteria: 1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study 2. Pregnant and lactating female patients 3. Patients with hypersensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, titanium, niobium, or any contrast media 4. Patients in whom anti-platelet and/or anticoagulant therapy are contraindicated 5. Patients with anatomical or clinical conditions which would make Transcatheter Aortic Valve Implantation (TAVI) unfeasible 6. Patients with ongoing infective endocarditis or any similar infection 7. Pre-existing prosthetic heart valve in any position 8. Highly decompensated left ventricular function (less than 20%) 9. Severely thickened left ventricular wall, with/without severely reduced ventricular cavity 10. Patients with severe aortic regurgitation without presence of aortic stenosis 11. Iliofemoral vessel characteristics or other conditions which would make transfemoral access unfeasible 12. Any condition, which, in Investigatorâ??s or heart teamâ??s opinion would preclude safe participation of patients in the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality All stroke Acute kidney injury Moderate or severe Prosthetic valve regurgitation Conduction disturbances and arrhythmias New permanent pacemaker implantation Major vascular complications Vascular and access related complications Echocardiography Short Form Survey (SF-12) New York Heart Association (NYHA) Functional Classification Re-Hospitalization Bleeding Myocardial Infarction Length of index hospital stay Cardiac structural complications Conversion to open surgery Unplanned use of mechanical circulatory support (cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), transcatheter pumps (e.g. Impella) or intra-aortic balloon pump (IABP) Implantation of multiple (1) transcatheter valves during the index hospitalization Valve malposition Aortic bioprosthetic valve dysfunction Bioprosthetic valve deterioration Technical success Device success Early safety Valve-related long-term clinical efficacy CT analysis Timepoint: Baseline, Index-procedure, Discharge,30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
Primary
| Measure | Time frame |
|---|---|
| It is a composite of: All-cause mortality All stroke Acute kidney injury Bleeding Moderate or severe paravalvular regurgitation Major vascular complications Conduction disturbances resulting in new permanent pacemaker implantationTimepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt. Ltd.
Outcome results
None listed