Portuguese Myval transcatheter aortic valve registry

Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

This project will try the Myval transcatheter heart valve in adults with symptomatic severe aortic stenosis who are having a TAVI procedure to see how safe and effective it is.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Portuguese Association of Interventional Cardiology (Academic / other)
• Locations: 6 sites (Carnaxide and 5 other locations)
• Trial ID: NCT06818435 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multicenter registry enrolling adults with symptomatic severe native aortic valve stenosis treated with the Myval transcatheter heart valve (THV) via TAVI. Patients are screened and selected by a local Heart Team, provide informed consent, and undergo the TAVI procedure using the Myval THV series. Clinical and safety outcomes are collected at the participating Portuguese centers and during scheduled follow-up visits. The registry is observational and aims to document real-world performance and adverse events associated with the device.

Who should consider this trial

Good fit: Adults (18+) with symptomatic severe native aortic stenosis who are planned for TAVI with the Myval THV by the Heart Team and can give informed consent and attend follow-up are ideal candidates.

Not a fit: Patients with active infection, major allergies to device or required medications, significant liver failure (Child-Pugh B/C), pregnant or lactating women, or those judged by the investigator as unsafe for participation are unlikely to benefit.

Why it matters

Potential benefit: If successful, the registry could show that the Myval valve is a safe and effective TAVI option that may improve symptoms and avoid open-heart surgery for some patients.

How similar studies have performed: TAVI as a technique has extensive supporting evidence, and prior registries and studies of Myval and similar THV devices have reported promising safety and performance, though data continue to be collected.

Eligibility criteria

Inclusion Criteria:

1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team.
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.

Where this trial is running

Carnaxide and 5 other locations

• Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz — Carnaxide, Portugal (Recruiting)
• Unidade Local de Saúde de Coimbra — Coimbra, Portugal (Recruiting)
• Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo — Evora, Portugal (Recruiting)
• Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta — Lisbon, Portugal (Not_yet_recruiting)
• Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria — Lisbon, Portugal (Recruiting)
• Unidade Local de São João E.P.E. — Porto, Portugal (Not_yet_recruiting)

Study contacts

• Study coordinator: Ana Domingues

Conditions Aortic Valve Stenosis; TAVI; MyPORTuVal; Portuguese TAVI Registry