Actively Recruiting
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform
Led by IRCCS Policlinico S. Donato · Updated on 2026-01-22
1000
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
Sponsors
I
IRCCS Policlinico S. Donato
Lead Sponsor
M
Meditrial SrL
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is referred for Navitor/Navitor Vision TAVI treatment by the local Heart Team
- Subject is legally able to provide consent in their country
- Subject has received information about the study and provided written informed consent approved by the Ethics Committee
You will not qualify if you...
- Pregnant or nursing individuals
- Need for emergency surgery for any reason
- Contraindications to Navitor/Navitor Vision TAVI including sepsis or active endocarditis
- Presence of left ventricular or atrial thrombus
- Vascular conditions preventing access to the aortic valve
- Non-calcified aortic annulus
- Leaflet configuration other than tricuspid
- Inability to tolerate antiplatelet or anticoagulant therapy
- Individuals who are mentally ill, severely demented, or lack legal authority
- Individuals unable to read or write
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy, 20097
Actively Recruiting
Research Team
L
Luca Testa, Principal Investigator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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