Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

Recruiting now

Conditions studied: Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation)

In brief

A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.

Key facts

Study ID

NCT06818435

Run by

Portuguese Association of Interventional Cardiology

People needed

150

Starts

2025-05-13

Expected to finish

2028-11-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patient has provided written informed consent as approved by the Ethics Committee (EC)
• Patient is willing to undergo all registry procedures and follow-up requirements

You may not qualify if…

• Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
• Ongoing infective endocarditis or any similar infection.
• Pregnant or lactating females.
• Liver failure (Child-Pugh Class B or C)
• Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
• Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.

Where it is running

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

Full record on ClinicalTrials.gov

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