Ireland
--:--IST
Latest
Clinical Trials in Portugal / NCT06818435
Recruiting Observational

Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

NCT06818435 · tracked via the Priya Life Science Portugal tracker
Sponsor
Portuguese Association of Interventional Cardiology
Phase
Observational
Started
2025-05-13
Last updated
2026-01-16

Condition(s) studied

Aortic Valve StenosisTAVI(Transcatheter Aortic Valve Implantation)

Investigational drug(s) / intervention(s)

Myval THV series

Myval THV series: Transcatheter Aortic Valve Implantation

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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

More Portuguese Association of Interventional Cardiology trials in Portugal

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06818435 on ClinicalTrials.gov ↗ ← All trials in Portugal