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.
1 other identifier
observational
200
6 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2020
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
ExpectedMarch 4, 2024
February 1, 2024
3.8 years
December 22, 2020
February 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (28)
All-cause mortality
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
Through 30 days
Bleeding type 3 and 4
Through 30 days
Moderate or severe prosthetic valve regurgitation
Through 30 days
- +23 more secondary outcomes
Interventions
Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.
Eligibility Criteria
All patients who have been treated with Myval™ THV series will be selected for the study.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
North Estonia Medical center
Tallinn, Estonia
Clinical Institute Saint Ambrogio
Milan, 20149, Italy
Amphia Ziekenhui
Breda, North Brabant, 4818, Netherlands
University of Gdansk
Gdansk, Bażyńskiego, 80-309, Poland
University Medical Centre Ljubljana
Ljubljana, Slovenia
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Cliinico Univertistario de Valladolid
Valladolid, 47003, Spain
Kocaeli University School of Medicine
Kocaeli, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ashok Thakkar, Ph.D.
Head - Clinical Research and Medical Writing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
January 11, 2021
Study Start
August 7, 2020
Primary Completion
May 30, 2024
Study Completion (Estimated)
November 30, 2028
Last Updated
March 4, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share