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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMeril Life Sciences Pvt. Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

No

Trial population

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

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • Myval Transcatheter Heart Valve Series

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
30 day

Secondary outcomes

1

All-cause mortality

Number of mortality as per VARC - 3 Criteria

Time frame
30 day
2

All stroke

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

Number of participants of AKI as per AKIN Network

Time frame
Through 30 days
4

Bleeding type 3 and 4

Number of participants for bleeding as per VARC-3 criteria

Time frame
Through 30 days

Other outcomes

Sponsors and contacts

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