Health Trials

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMeril Life Sciences Pvt. Ltd.

About this trial

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)

The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥18 years of age.

Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study.

As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.

Disqualifiers

Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.

Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myval THV Series

    Device

    The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

  • Contemporary Valves (Sapien THV Series and Evolut THV Series)

    Device

    The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

Treatment groups

988 Participants
are divided into 4 treatment groups
Group A: Myval THV SeriesExperimental treatment 1 intervention
Group B: Contemporary ValvesActive comparator 1 intervention
Group C: Myval THV Series XL Nested RegistryExperimental treatment 1 intervention
Group D: Myval THV Series Lead-in SetExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)

It is the composite of following: * All-cause mortality * All stroke * Bleeding (Type 3 and 4) * Acute kidney injury (AKI) (Stage 2, 3 and 4) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new PPI

Time frame
30-day

Secondary outcomes

1

The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)

It is the composite of following: * All-cause mortality * All stroke * Bleeding (Type 3 and 4) * AKI (Stage 2, 3 and 4) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new PPI

Time frame
1-year
2

All-cause mortality

As per VARC-3 defined criteria

Time frame
Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year
3

All stroke

As per VARC-3 defined criteria

Time frame
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
4

Acute Kidney Injury (AKI) (Stage 2, 3 and 4)

As per VARC-3 defined criteria

Time frame
Pre-discharge, 30-day, and 1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meril Life Sciences Pvt. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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