Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Sahajanand Medical Technologies Limited (SMT)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients affected by symptomatic severe aortic stenosis (NYHA class = II) eligible for TAVI procedure as per local Heart Team evaluation 2. Full understanding and willing to provide informed consent to study enrolment
Exclusion criteria
Exclusion criteria: 1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis) 2. Refusal to provide informed consent to study enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Cardiovascular mortality Primary performance endpoint: Device successTimepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute kidney injuryTimepoint: 30 days;All strokeTimepoint: 30 days, 1, 3, and 5 years;All-cause mortality (cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality)Timepoint: 30 days, 1, 3, and 5 years;Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditisTimepoint: 30 days, 1, 3, and 5 years;Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deteriorationTimepoint: 30 days, 1, 3, and 5 years;Coronary artery obstruction requiring interventionTimepoint: 30 days, 1, 3, and 5 years;Disabling strokeTimepoint: 30 days, 1, 3, and 5 years;Effective Orifice Area (EOA)Timepoint: 30 days, 1, 3, and 5 years;Life threatening bleedingTimepoint: 30 days;Major vascular complicationTimepoint: 30 days;Mean aortic valve gradientTimepoint: 30 days, 1, 3, and 5 years;Myocardial infarctionTimepoint: 30 days, 1, 3, and 5 years;New permanent pacemaker implantation due to procedure related conduction abnormalitiesTimepoint: 30 days, 1, 3, and 5 years;New York Heart Association (NYHA) functional classTimepoint: 30 days, 1, 3, and 5 years;Paravalvular leakTimepoint: 30 days, 1, 3, and 5 years;Quality-of-life evaluationTimepoint: 30 days, 1, 3, and 5 years;Re-hospitalization for procedure- or valve-related causesTimepoint: 30 days, 1, 3, and 5 years;Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)Timepoint: 30 days, 1, 3, and 5 years;VARC-3 Type 2–4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)Timepoint: 30 days, 1, 3, and 5 years | — |
Countries
India
Contacts
Public ContactDr Rajiv Narang
All India Institute of Medical Science
Outcome results
None listed