Clareo Health | PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Portuguese Association of Interventional Cardiology
With
Medtronic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects more than 18 years old, able to provide an Informed Consent:
Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;
Subjects provided written Informed Consent as approved by the Ethics Committee (EC);
You may not be if
Subjects with pre-existing surgical bioprosthetic aortic valve;
Hepatic insufficiency (Child-Pugh Class B or C);
Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);
Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;
Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
Subjects have an expected survival less than one year.
