INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor/Navitor Vision Transcatheter Aortic Valve (Navitor/Navitor Vision Valve) in patients with symptomatic, severe native aortic stenosis to monitor the outcomes of this valve in a real-world clinical setting.
Subject is referred to receive a Navitor/Navitor Vision TAVI according to the local Heart Team. The Heart Team determines the indication to TAVI with Navitor/Navitor Vision before the possible enrolment and independently from the study.
Subject is of legal age for consent in the host country.
Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site.
Pregnant or nursing subjects
Need for emergency surgery for any reason
Any sepsis, including active endocarditis
Any evidence of left ventricular or atrial thrombus