Clinical Trials in Italy / NCT07359898
Recruiting
Observational
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform
NCT07359898 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Severe Native Aortic Stenosis
Study 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 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
Primary outcome measure(s)
- All-Cause Mortality — 12 months
The primary endpoint is all-cause mortality at 12 months after the index Navitor/Navitor Vision implantation procedure.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Policlinico San Donato | San Donato Milanese | Lombardy | Recruiting |
More IRCCS Policlinico S. Donato trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07359898 on ClinicalTrials.gov ↗ ← All trials in Italy