Health Condition 1: Z952- Presence of prosthetic heart valve
Conditions
Interventions
None listed
Sponsors
DrAshok Seth Fortis Escorts Heart Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who were confirmed to have native BAV stenosis by computed tomography (CT). 2) Patients who were eligible for TAVI with an EvolutTM series device, as determined by the Heart Team. 3) Patients who have been implanted with a Evolut• series device and have completed at least 1 year of follow-up at the time of data extraction. 4) Patients who have undergone/underwent implantation with a Evolut• series device and will be followed up prospectively until they complete 1 year of follow-up from the date of implant. 5) Patients willing to provide informed consent for further follow-up in the study.
Exclusion criteria
Exclusion criteria: 1) Ongoing sepsis, including active endocarditis 2) Anatomically not suitable for the EvolutTM series of devices 3) Estimated life expectancy of less than 1 year 4) Need for emergency surgery for any reason 5) Any condition which in the investigators opinion would preclude safe participation of the patient in the study 6) Pregnant and lactating women 7) Patients with unicuspid aortic valve 8) Severe mitral or tricuspid regurgitation that requires repair or replacement of the valve 9) Participating in another study which may influence the outcome of this study 10) Patients who are already implanted with an EvolutTM series device but complete data are not available and or follow-up is not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To analyze the clinical outcomes of TAVI using a supra-annular THV in BAV stenosis in relationship to phenotypic classification and valve sizing algorithms.Timepoint: In-hospital and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the echocardiographic outcomes at baseline post procedure 30 days and 1 year Effective orifice area Index effective orifice area Mean aortic valve gradient Peak aortic valve gradient Peak aortic velocity Transvalvular regurgitation and paravalvular regurgitation (mild moderate and severe) Left ventricular ejection fraction Doppler velocity index To assess the unplanned use of mechanical circulatory support cardiopulmonary bypass (CPB) extracorporeal membrane oxygenation transcatheter pumps or intra-aortic balloon pump (in-hospital)Timepoint: In hospital and 12 months | — |
Countries
India
Contacts
Public ContactDrAshok Seth
Fortis Escorts Heart Institute
Outcome results
None listed