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

Meril Life Sciences

Status: Enrolling

Conditions: Aortic Valve Stenosis

Treatments: Device: Myval Transcatheter Heart Valve Series

Study type: Observational

Funder types: Industry

Identifiers

NCT04703699

MLS/MYV-3/Global study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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