Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting.~This study shall retrospectively collect the data of minimum 200 consecutive patients treated with Myval THV system between 01-June-2019 to 30-June-2020 from approximately 15 participating sites in Europe.~Primary Endpoint:~Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]~It is the composite of following:~All-cause mortality~All stroke (disabling and non-disabling)~Life-threatening or disabling bleeding~Acute kidney injury (stage 2 or 3)~Major vascular complications~Moderate or severe prosthetic valve regurgitation~Conduction system disturbances resulting in a new permanent pacemaker implantation.~Secondary endpoints:~All-cause mortality (VARC-2 defined criteria) [Time Frame: Through 30 days]~All stroke (disabling and non-disabling) [Time Frame: Through 30 days]~Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline~Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline~Note: As per VARC-2, the assessment of the mRS should be done at all scheduled visits in a trial and at 90 days after the onset of any stroke.~Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2 [Time Frame: Through 30 days]~Life-threatening or disabling bleeding (VARC-2 criteria) [Time Frame: Through 30 days]~Moderate or severe prosthetic valve regurgitation [Time Frame: Through 30 days]~New permanent pacemaker implantation [Time Frame: Through 30 days] New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block.~Conduction disturbances and arrhythmias according to VARC-2 [Time Frame: Through 30 days]~Device success (VARC-2 criteria) [Time Frame: Pre-discharge]~Early safety at 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]~Clinical efficacy after 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]~Time-related valve safety (VARC-2 criteria) [Time Frame: Through 30 days]~Vascular and access related complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days]~Major vascular complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days]~Functional improvement from baseline as measured per~a. NYHA functional classification [Time frame: Baseline, 30 days]~Echocardiographic End Points~Effective orifice area (EOA)~Index effective orifice area (iEOA)~Mean aortic valve gradient~Peak aortic valve gradient~Peak aortic velocity~Transvalvular, paravalvular and total aortic regurgitation~Left ventricular ejection fraction (LVEF)~Valve calcification~Cardiac output and cardiac index [Time frame: Through 30 days]~Patient-prosthesis Mismatch: [Time Frame: Post-procedure, predishcarge, Through 30 days] Severity patient-prosthesis-mismatch will be based on following~For subjects with BMI < 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.65 cm2 /m2 for moderate and <0.65 cm2 /m2 for severe~For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.90 - 0.60 cm2 /m2 for moderate and <0.60 cm2 /m2 for severe BMI = weight(kg)/(height (m)) 2~Length of index hospital stay. [Time frame: At discharge]~- Number of days from hospital admission to discharge.~Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) [Time Frame: Through 30 days]~New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days]~Endocarditis [Time Frame: Through 30 days]~Major bleeding event [Time Frame: Through 30 days]~Other Endpoints:~Myocardial rupture [Time Frame: During procedure]~Paravalvular leak [Time Frame:Through 30 days]~Degree of over- or under-expansion of Myval [Time Frame: During procedure]~Accuracy of deployment in relation to the annular plane [Time Frame: During procedure]~Pacemaker deployment (and the symptoms resulting in it) [Time Frame: Through 30 days]~Interference with the mitral valve; and [Time Frame: During procedure]~Interference with the LVOT [Time Frame: During procedure]~If the endpoint data is available through 1 year, it will also be collected and analyzed.~Clinical efficacy data will be collected only for patients with availability of data after 30 days follow-up.~Long term clinical follow up by telephonic interview will be conducted for all patients who have completed 30 days safety follow-up, at 1 year, 3 year and 5 years.
Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting.