Actively Recruiting
Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
Led by Portuguese Association of Interventional Cardiology · Updated on 2026-01-16
150
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
Sponsors
P
Portuguese Association of Interventional Cardiology
Lead Sponsor
M
Meril Life Sciences Pvt. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Myval THV series device used in Transcatheter Aortic Valve Implantation TAVI procedures for patients with symptomatic severe native aortic valve stenosis. This prospective, single-arm, multi-centre registry aims to gather real-world data on this treatment approach to better understand its use in this condition. Participants will undergo the TAVI procedure using the Myval THV series device. The study is observational and does not involve comparison groups or placebo treatments. The registry will collect data on the procedure and device performance over time, focusing on safety outcomes within 30 days and extending observations up to 12 months. During the study, participants will be monitored through registry procedures and follow-up visits. Researchers will assess safety outcomes at 30 days and measure both safety and performance at 30 days and 12 months after the procedure. Participants will provide informed consent and are expected to comply with all registry requirements, including follow-up evaluations.
CONDITIONS
Brief Title
Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over the age of 18 years with symptomatic severe aortic stenosis, planned for TAVI procedure using Myval THV series as assessed by Heart Team
- Patient has provided written informed consent approved by the Ethics Committee
- Patient is willing to undergo all registry procedures and follow-up requirements
You will not qualify if you...
- Allergy or hypersensitivity to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum, or any contrast media
- Ongoing infective endocarditis or similar infection
- Pregnant or lactating females
- Liver failure classified as Child-Pugh Class B or C
- Currently participating in another clinical investigation with an unmet primary endpoint
- Any condition that the investigator believes would prevent safe participation in the registry
Research Team
A
Ana Domingues
J
Joana D Silva, MD
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