Myval European Study of Myval™ THV System Implanted in Patients With Native Severe Aortic Valve Stenosis.

  • STATUS
    Recruiting
  • End date
    Nov 30, 2026
  • participants needed
    200
  • sponsor
    Meril Life Sciences Pvt. Ltd.
Updated on 28 July 2022
stenosis
aortic valve stenosis

Summary

Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting.

Description

Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting.

This study shall retrospectively collect the data of minimum 200 consecutive patients treated with Myval THV system between 01-June-2019 to 30-June-2020 from approximately 15 participating sites in Europe.

Primary Endpoint:

Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]

It is the composite of following:

  • All-cause mortality
  • All stroke (disabling and non-disabling)
  • Life-threatening or disabling bleeding
  • Acute kidney injury (stage 2 or 3)
  • 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-2 defined criteria) [Time Frame: Through 30 days]
  2. All stroke (disabling and non-disabling) [Time Frame: Through 30 days]
    • Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline
    • Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline

Note: As per VARC-2, the assessment of the mRS should be done at all scheduled visits in a trial and at 90 days after the onset of any stroke.

3. Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2 [Time Frame: Through 30 days]

4. Life-threatening or disabling bleeding (VARC-2 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-2 [Time Frame: Through 30 days]

8. Device success (VARC-2 criteria) [Time Frame: Pre-discharge]

9. Early safety at 30 days (VARC-2 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-2 criteria) [Time Frame: Pre-discharge, Through 30 days]

13. Major vascular complications (VARC-2 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 - 0.65 cm2 /m2 for moderate and <0.65 cm2 /m2 for severe
    • For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.90 - 0.60 cm2 /m2 for moderate and <0.60 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.
  5. Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) [Time Frame: Through 30 days]
  6. New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days]
  7. Endocarditis [Time Frame: Through 30 days]
  8. Major bleeding event [Time Frame: Through 30 days]
  9. 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.

Details
Condition Aortic Valve Stenosis
Treatment Myval Transcatheter Heart Valve System
Clinical Study IdentifierNCT04703699
SponsorMeril Life Sciences Pvt. Ltd.
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All patients of this study must have received Myval THV system for treatment of native severe aortic stenosis and meet all eligibility and treatment criteria as defined by Hospital Heart Team and or Treating TAVR operator

Exclusion Criteria

No
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