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

Summary

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.

Eligibility

Inclusion Criteria:

1. 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.
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

Conditions2

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