Description

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
    1. NYHA functional classification \[Time frame: Baseline, 30 days\]
    2. 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 \[Time frame: Through 30 days\]
    3. 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
    4. 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.