Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPortuguese Association of Interventional Cardiology
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Myval THV series
Treatment groups
No treatment groups listed
Locations
6Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz2790-134, Carnaxide Portugal
Unidade Local de Saúde de Coimbra3004-561, Coimbra Portugal
Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo7000-811, Evora Portugal
Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria1649-035, Lisbon Portugal
Sponsors and collaborators
Portuguese Association of Interventional Cardiology
Lead sponsor
Meril Life Sciences Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov