NCT07532317

A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluatesafety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared toGuideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 778 (estimated)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	Myval THV Series will include Myval/Myval Octacor/OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site. Participants in the GDMT arm will receive guideline-directed medical therapy based on their clinical condition and in accordance with hospital standard practice based on European Society of Cardiology / European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association/ American College of Cardiology/ Heart Failure Society of America (AHA/ACC/HFSA) Heart Failure (HF) guidelines and its subsequent updates

Timeline

• Start date: 2026-05-17
• Primary completion: 2028-05-12
• Completion: 2038-05-12
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

62 sites across 20 countries: Australia, Belarus, Brazil, Denmark, Estonia, Finland, France, Germany, Italy, Netherlands, New Zealand, North Macedonia, Norway, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom