To Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared toGuideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.
brief 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.
detailed description
Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab.
Note: The detailed definitions and criterias for moderate AS are provided in inclusion criteria.
Clinical and echocardiographic follow-up at:
Pre-discharge \[Prior to hospital discharge (within 24 hours of the date of discharge) or maximum of 7 days after index procedure, whichever occurs earlier\] \[Applicable for the TAVI arm only\] 30-day (+ 7 days) \[Applicable for the TAVI arm only\] 6-month (+ 15 days)
1-year (+ 30 days) 1.5-year (+ 30 days) 2-year (+ 30 days) 2.5-year (+ 30 days) 3-year (+ 30 days) 5-year (+ 30 days) 10-year (+ 30 days)
Telephonic follow-up at:
4-year (+ 30 days) 6-year (+ 30 days) 7-year (+ 30 days) Note: For participants randomized to the GDMT arm who subsequently undergo AVR or any other intervention at the investigator's discretion, a follow-up visit will be performed at 30 days after the procedure, with an additional follow-up at 1 year (recommended). Thereafter, participants will continue with the remaining scheduled study follow-up visits as per their original study timeline.
official title
A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared to Guideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.