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Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis

ConditionModerate Aortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMeril Life Sciences Pvt. Ltd.

About this trial

The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with ≥ 65 years of age.

Participant has provided written informed consent as approved Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) of the investigational site to participate in the study.

Participant with moderate aortic stenosis, defined as one of the following

Peak aortic jet velocity (Vmax) ≥ 3.0 m/s and < 4.0 m/s, or

Disqualifiers

Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve.

Aortic valve is unicuspid or non-calcified as verified by echocardiography/CT.

Renal insufficiency with glomerular filtration rate (GFR) < 30 mL/min and/or need for renal replacement therapy.

Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcatheter aortic valve Implantation

    Device

    Myval THV Series will include Myval/Myval Octacor/ OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site.

Treatment groups

778 Participants
are divided into 2 treatment groups
Group A: Guideline-directed medical therapyNo intervention 0 interventions
Group B: Transcatheter Aortic Valve ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Efficacy Endpoint

It is the composite of following: All-cause mortality, Disabling stroke, Aortic valve replacement due to advanced valve syndrome (AVS), Heart failure hospitalization, Deterioration in quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years or at the time of conversion to AVR in the GDMT arm.

Time frame
2-year

Secondary outcomes

1

All-cause mortality

As per VARC-3 defined criteria

Time frame
Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year
2

All stroke

As per VARC-3 defined criteria

Time frame
Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
3

Acute Kidney Injury (AKI)

As per VARC-3 defined criteria

Time frame
Pre-discharge, 30-day
4

Bleeding (Type 2, 3 and 4)

As per VARC-3 defined criteria

Time frame
Predischarge, 30-day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Meril Life Sciences Pvt. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: