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

Aortic Valve Stenosis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

• NCT number: NCT04703699
• Study type: Observational
• Source: Meril Life Sciences Pvt. Ltd.
• Contact: Ashok Thakkar, Ph.D.
• Phone: +91-260-3063880
• Email: Ashok.Thakkar@merillife.com
• Status: Recruiting
• Start date: August 7, 2020
• Completion date: November 30, 2028