International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform
Key facts
- Where
- San Donato Milanese, ItalySee the site
Where in Italy
- IRCCS Policlinico San DonatoSan Donato Milanese, ItalyContact: Luca Testa, Principal InvestigatorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- IRCCS Policlinico S. Donato
- Trial code
- NCT07359898
- Record updated
- 24 July 2026
- Original description
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.Read full original descriptionShow less
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform (The Intensive Study)
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.
Inclusion: Subject is referred to undergo TAVI with a Navitor/Navitor Vision valve according to the local Heart Team. The Heart Team determines the indication for TAVI with Navitor/Navitor Vision before possible enrolment and independently of 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.
Exclusion: Need for emergency surgery for any reason; Contraindications to Navitor/Navitor Vision TAVI according to the IFU:; Any sepsis, including active endocarditis; Any evidence of left ventricular or atrial thrombus; Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible; Non-calcified aortic annulus; Any leaflet configuration other than tricuspid; Inability to tolerate antiplatelet/anticoagulant therapy; Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority; Pregnant or nursing subjects; Individuals who are unable to read or write.