Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry

Launched by PORTUGUESE ASSOCIATION OF INTERVENTIONAL CARDIOLOGY · Feb 5, 2025

Keywords

ClinConnect Summary

The MyPORTuVal Registry is a clinical trial aimed at studying a new type of heart valve called Myval, which is used in a procedure known as Transcatheter Aortic Valve Implantation (TAVI). This trial will look at how safe and effective the Myval heart valve is for patients who have severe aortic valve stenosis, a condition where the valve does not open properly, causing problems with blood flow. The trial is open to adults over 18 years old who are experiencing symptoms of this condition and are approved by a team of doctors.

Participants in this study will be required to give their written consent and agree to follow all study procedures and check-ups. However, certain individuals won't be able to participate, such as those with specific allergies, ongoing infections, or other serious health issues. It's important for potential participants to know that the registry is not yet recruiting patients, but it will provide valuable information that could help improve treatment for people with aortic valve stenosis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
• • 2. Patient has provided written informed consent as approved by the Ethics Committee (EC)
• • 3. Patient is willing to undergo all registry procedures and follow-up requirements
• Exclusion Criteria:
• • 1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
• • 2. Ongoing infective endocarditis or any similar infection.
• • 3. Pregnant or lactating females.
• • 4. Liver failure (Child-Pugh Class B or C)
• • 5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
• • 6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.