International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform

Recruiting now

Conditions studied: Severe Native Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07359898

Run by

IRCCS Policlinico S. Donato

People needed

1000

Starts

2025-10-11

Expected to finish

2031-10-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or nursing subjects
• 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
• Individuals who are unable to read or write

Where it is running

• IRCCS Policlinico San Donato — San Donato Milanese, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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