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

Sponsor
Meril Life Sciences Pvt. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04703699
Collaborator
(none)
200
10
75.8
20
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Myval Transcatheter Heart Valve System

Detailed 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.

  1. 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]

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

  3. Moderate or severe prosthetic valve regurgitation [Time Frame: Through 30 days]

  4. 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.

  5. Conduction disturbances and arrhythmias according to VARC-2 [Time Frame: Through 30 days]

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

  7. Early safety at 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]

  8. Clinical efficacy after 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure]

  9. Time-related valve safety (VARC-2 criteria) [Time Frame: Through 30 days]

  10. Vascular and access related complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days]

  11. Major vascular complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days]

  12. Functional improvement from baseline as measured per

  1. NYHA functional classification [Time frame: Baseline, 30 days]
  1. 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]

  1. 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

  1. Length of index hospital stay. [Time frame: At discharge]
  • Number of days from hospital admission to discharge.
  1. Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) [Time Frame: Through 30 days]

  2. New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days]

  3. Endocarditis [Time Frame: Through 30 days]

  4. Major bleeding event [Time Frame: Through 30 days]

  5. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Aug 7, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Nov 30, 2026

Outcome Measures

Primary Outcome Measures

  1. Safety and Effectiveness as defined by the Valve Academic Research Consortium-2 (VARC-2) [30 day]

    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 Outcome Measures

  1. All-cause mortality [30 day]

    Number of mortality as per VARC - 2 Criteria

  2. All stroke (disabling and non-disabling) [Through 30 days]

    Number of participants as per following criteria. 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

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

    Number of participants of AKI as per AKIN Network

  4. Life-threatening or disabling bleeding [Through 30 days]

    Number of participants for Life-threatening or disabling bleeding as per VARC-2 criteria

  5. Moderate or severe prosthetic valve regurgitation [Through 30 days]

    VARC -2 criteria

  6. New permanent pacemaker implantation [Through 30 days]

    Number of participants for 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 [Through 30 days]

    Number of participants for Conduction disturbances and arrhythmias as per VARC-2 Criteria

  8. Device Success [During hospital stay or maximum of 7 days after index procedure, whichever is earlier.]

    Number of participants for Device success as per VARC-2 Criteria

  9. Early safety at 30 days [After 30 days of index procedure]

    Number of participants for Early safety as per VARC-2 Criteria

  10. Clinical efficacy after 30 days [After 30 days of index procedure]

    Number of participants for Clinical efficacy as per VARC-2 Criteria

  11. Time related valve safety [Through 30 days]

    Number of participants for Time related valve safety as per VARC-2 Criteria

  12. Vascular and access related complications [Immediately after procedure, at 1 Month]

    Number of participants for Vascular and access related complications as per VARC-2 Criteria

  13. Major vascular complications [Immediately after procedure, at 1 Month]

    Number of participants for Major vascular complications as per VARC-2 Criteria

  14. Functional improvement from baseline as measured [Baseline, 30 days]

    Number of participants for Functional improvement as per NYHA functional classification

  15. Acceptability Echocardiographic End Points [At 1 Month]

    Outcome measures will be: 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

  16. Patient-prosthesis Mismatch [At 1 Month]

    Number of participants for Patient-prosthesis Mismatch as per VARC 2 criteria

  17. Length of index hospital stay [At 1 Month]

    Number of days from hospital admission to discharge

  18. Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) [Through 30 days]

    As per NYHA criteria

  19. New onset of atrial fibrillation or atrial flutter [At 1 Month]

    VARC-2 criteria

  20. Endocarditis [Through 30 days]

    Number of participantsfor Endocarditis as per VARC-2 criteria

  21. Major bleeding event [Through 30 days]

    Number of participants for Major bleeding event as per VARC-2 criteria

  22. Myocardial rupture [During procedure]

    Number of participants for Myocardial rupture

  23. Paravalvular Leak [Through 30 days]

    Number of participants for Paravalvular Leak

  24. Degree of over - or Under-expansion of Myval [During Procedure]

    Number of participants for Degree of over - or Under-expansion of Myval

  25. Accuracy of deployment in relation to the annular plane [During procedure]

    Number of participants for Accuracy of deployment in relation to the annular plane

  26. Pacemaker deployment (and the symptoms resulting in it) [Through 30 days]

    Number of participants for Pacemaker deployment (and the symptoms resulting in it)

  27. Interference with the mitral valve [During procedure]

    Number of participants for Interference with the mitral valve

  28. Interference with the LVOT [During procedure]

    Number of participants for Interference with the LVOT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikums Braunschweig Braunschweig Freisestre Germany 38118
2 Clinical Institute Saint Ambrogio Milano Italy 20149
3 Montevergine hospital Radda in Chianti Italy 53017
4 Vilnius university hospital Vilnius Lithuania 08661
5 University Medical Center (UMC) Groningen GZ Groningen Netherlands 9713
6 Amphia Ziekenhui Breda North Brabant Netherlands 4818
7 University of Gdansk Gdańsk Bażyńskiego Poland 80-309
8 Centro Hospitalar Lisboa Ocidental EPE Carnaxide Portugal 2790-134
9 Hospital Universitario de Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain 35010
10 Hospital Cliinico Univertistario de Valladolid Valladolid Spain 47003

Sponsors and Collaborators

  • Meril Life Sciences Pvt. Ltd.

Investigators

  • Study Chair: Ashok Thakkar, Ph.D., Head - Clinical Research and Medical Writing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meril Life Sciences Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT04703699
Other Study ID Numbers:
  • MLS/MYV-3/European study
First Posted:
Jan 11, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022