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โ† Trials
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International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform

Recruitingn/aAges 18 Years - anyAllIRCCS Policlinico S. Donato
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. Subject is of legal age for consent in the host country. 3. 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 Criteria: 1. Pregnant or nursing subjects 2. Need for emergency surgery for any reason 3. Contraindications to Navitor/Navitor Vision TAVI according to the IFU: 1. Any sepsis, including active endocarditis 2. Any evidence of left ventricular or atrial thrombus 3. Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible 4. Non-calcified aortic annulus 5. Any leaflet configuration other than tricuspid 6. Inability to tolerate antiplatelet/anticoagulant therapy 4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority 5. Individuals who are unable to read or write
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What it tests

  • Not listed
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Where

1 site
IRCCS Policlinico San Donato
San Donato Milanese, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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