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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
North Estonia Medical center
Tallinn, Estonia
Clinical Institute Saint Ambrogio
Milan, Italy
Amphia Ziekenhui
Breda, North Brabant, Netherlands
University of Gdansk
Gdansk, Bażyńskiego, Poland
University Medical Centre Ljubljana
Ljubljana, Slovenia
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Hospital Cliinico Univertistario de Valladolid
Valladolid, Spain
Kocaeli University School of Medicine
Kocaeli, Turkey (Türkiye)
Start Date
August 7, 2020
Primary Completion Date
May 30, 2024
Completion Date
November 30, 2028
Last Updated
March 4, 2024
200
ESTIMATED participants
Myval Transcatheter Heart Valve Series
DEVICE
Lead Sponsor
Meril Life Sciences Pvt. Ltd.
NCT07477002
NCT05672836
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05386173