myval global study of myval™ thv series implanted in patients with native severe aortic valve stenosis.

Conditions: Aortic Valve Stenosis

Summary: a retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with myval™ transcatheter heart valve series in real-world setting.

myval global study: a retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with myval™ transcatheter heart valve series in real-world setting. this study shall retrospectively collect the data of minimal 200 consecutive patients treated with myval™ thv series approximately 15 participating sites globally. primary endpoint: primary combined safety and effectiveness endpoint: \[time frame: 30 days\] it is the composite of following: * all-cause mortality * all stroke * bleeding (type 3 and 4) * acute kidney injury (stage 2 ,3 \& 4) * major vascular complications * moderate or severe prosthetic valve regurgitation * conduction system disturbances resulting in a new permanent pacemaker implantation. secondary endpoints: 1. all-cause mortality (varc-3 defined criteria) \[time frame: through 30 days\] 2. all stroke (varc-3 defined criteria) \[time frame: through 30 days\] 3. acute kidney injury (aki) based on the acute kidney injury network (akin) system stage 2, stage 3 or stage 4 \[time frame: through 30 days\] 4. bleeding type 3 and 4 (varc-3 criteria) \[time frame: through 30 days\] 5. moderate or severe prosthetic valve regurgitation \[time frame: through 30 days\] 6. 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. 7. conduction disturbances and arrhythmias according to varc-3 \[time frame: through 30 days\] 8. device success (varc-3 criteria) \[time frame: pre-discharge\] 9. early safety at 30 days (varc-3 criteria) \[time frame: after 30 days of index procedure\] 10. clinical efficacy after 30 days (varc-2 criteria) \[time frame: after 30 days of index procedure\] 11. time-related valve safety (varc-2 criteria) \[time frame: through 30 days\] 12. vascular and access related complications (varc-3 criteria) \[time frame: pre-discharge, through 30 days\] 13. major vascular complications (varc-3 criteria) \[time frame: pre-discharge, through 30 days\] 14. functional improvement from baseline as measured per a. nyha functional classification \[time frame: baseline, 30 days\] 15. 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 \[time frame: through 30 days\] 16. 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 - 0.66 cm2 /m2 for moderate and ≤0.65 cm2 /m2 for severe * for subjects with bmi ≥30 kg/m2, index effective orifice area (eoai) 0.70 - 0.56 cm2 /m2 for moderate and ≤0.55 cm2 /m2 for severe bmi = weight(kg)/(height (m)) 2 17. length of index hospital stay. \[time frame: at discharge\] - number of days from hospital admission to discharge. 18. re-hospitalization (varc-3 defined criteria) \[time frame: through 30 days\] 19. new onset of atrial fibrillation or atrial flutter \[time frame: post-procedure, pre-discharge and 30 days\] 20. endocarditis \[time frame: through 30 days\] 21. major bleeding event \[time frame: through 30 days\] 22. 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.

Eligibility criteria:
inclusion criteria: * all patients of this study must have received myval™ thv series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up. exclusion criteria: * no