NCT04703699

Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Myval Transcatheter Heart Valve Series	Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.

Timeline

• Start date: 2020-08-07
• Primary completion: 2024-05-30
• Completion: 2028-11-30
• First posted: 2021-01-11
• Last updated: 2024-03-04

Locations

8 sites across 7 countries: Estonia, Italy, Netherlands, Poland, Slovenia, Spain, Turkey (Türkiye)