Clinical Trial

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

Not Yet Recruiting
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Summary
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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-05-07
notable Trial sites reduced: 62 -> 0 locations 2026-05-07
notable Primary completion pushed: 2028-05-12 -> 2031-05-12 2026-05-07
minor Completion pushed: 2038-05-12 -> 2041-05-12 2026-05-07
critical Primary endpoint(s) modified 2026-04-21
Trial Details
NCT Number NCT07532317
Lead Sponsor Meril Life Sciences Pvt. Ltd.
Conditions Moderate Aortic Stenosis
Enrollment 778 participants
Start Date 2026-05-17
Primary Completion 2031-05-12 (estimated)
Study Completion 2041-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-06