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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Myval Transcatheter Heart Valve Series

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ashok Thakkar, Ph.D.; Phone Number: 242 +91-260-3063880; Email: Ashok.Thakkar@merillife.com

Study Locations

• Estonia
  • Tallinn, Estonia
    • Recruiting
    • North Estonia Medical Center
    • Contact: Dr. Peep Laanmets; Email: peep.laanmets@regionaalhaigla.ee
• Italy
  • Milano, Italy, 20149
    • Recruiting
    • Clinical Institute Saint Ambrogio
    • Contact: Dr. Alfonso Ielasi, MD; Phone Number: +39 338 8433189; Email: alielasi@hotmail.com
• Netherlands
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818
      • Recruiting
      • Amphia Ziekenhui
      • Sub-Investigator: Simsek Cihan, Ph.D
      • Contact: Dr. A. J. J. IJsselmuiden, MD, Ph.D; Phone Number: +31(0)655814502; Email: siisselmuiden@amphia.nl
• Poland
  • Bażyńskiego
    • Gdańsk, Bażyńskiego, Poland, 80-309
      • Recruiting
      • University of Gdansk
      • Contact: Prof. Dariusz Jagielak, MD, PhD; Phone Number: +48509487577; Email: darjag@gumed.edu.pl
• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: Prof. Matjaz Bunc; Email: matjaz.bunc@kclj.si
• Spain
  • Las Palmas De Gran Canaria, Spain, 35010
    • Recruiting
    • Hospital Universitario de Gran Canaria Dr. Negrin
    • Contact: Dr. Pedro Martin Lorenzo; Phone Number: +34 616 129540 / 928 284105; Email: pemarlor@hotmail.com
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Cliinico Univertistario de Valladolid
    • Contact: Dr. Ignacio A Santos, Medicine & Surgery; Phone Number: +34657923040; Email: ijamat@gmail.com
    • Sub-Investigator: Jose R Delgado Arana, Medicine
• Turkey
  • Kocaeli, Turkey
    • Recruiting
    • Kocaeli University School of Medicine
    • Contact: Prof. Teoman Kilic; Email: kilicteoman@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who have been treated with Myval™ THV series will be selected for the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)	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	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy after 30 days	Number of participants for Clinical efficacy as per VARC-2 Criteria	After 30 days of index procedure
Time related valve safety	Number of participants for Time related valve safety as per VARC-2 Criteria	Through 30 days
Functional improvement from baseline as measured	Number of participants for Functional improvement as per NYHA functional classification	Baseline, 30 days
Myocardial rupture	Number of participants for Myocardial rupture	During procedure
Paravalvular Leak	Number of participants for Paravalvular Leak	Through 30 days
Degree of over - or Under-expansion of Myval	Number of participants for Degree of over - or Under-expansion of Myval	During Procedure
Accuracy of deployment in relation to the annular plane	Number of participants for Accuracy of deployment in relation to the annular plane	During procedure
Pacemaker deployment (and the symptoms resulting in it)	Number of participants for Pacemaker deployment (and the symptoms resulting in it)	Through 30 days
Interference with the mitral valve	Number of participants for Interference with the mitral valve	During procedure
Interference with the LVOT	Number of participants for Interference with the LVOT	During procedure
All-cause mortality	Number of mortality as per VARC - 3 Criteria	30 day
All stroke		Through 30 days
Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4	Number of participants of AKI as per AKIN Network	Through 30 days
Bleeding type 3 and 4	Number of participants for bleeding as per VARC-3 criteria	Through 30 days
Moderate or severe prosthetic valve regurgitation		Through 30 days
New permanent pacemaker implantation	New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block	Through 30 days
Conduction disturbances and arrhythmias	Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria	Through 30 days
Device Success	Number of participants for Device success as per VARC-3 Criteria	During hospital stay or maximum of 7 days after index procedure, whichever is earlier.
Early safety at 30 days	Number of participants for Early safety as per VARC-3 Criteria	After 30 days of index procedure
Vascular and access related complications	Number of participants for Vascular and access related complications as per VARC-3 Criteria	Pre-discharge, Through 30 days
Major vascular complications	Number of participants for Major vascular complications as per VARC-3 Criteria	Pre-discharge, Through 30 days
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	Through 30 days]
Patient-prosthesis Mismatch	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	Through 30 days
Length of index hospital stay	Number of days from hospital admission to discharge	At discharge
Re-hospitalization	Number of participants as per VARC-3 defined criteria	Through 30 days
New onset of atrial fibrillation or atrial flutter	VARC-3 criteria	Post-procedure, Pre-discharge and 30 days
Endocarditis	Number of participants for Endocarditis as per VARC-3 criteria	Through 30 days
Major bleeding event	Number of participants for Major bleeding event as per VARC-3 criteria	Through 30 days

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Investigators: Study Chair: Ashok Thakkar, Ph.D., Head - Clinical Research and Medical Writing

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: MLS/MYV-3/Global study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No