International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve P
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.
| Condition(s) | Severe Native Aortic Stenosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | IRCCS Policlinico S. Donato |
| Locations | San Donato Milanese, Lombardy, Italy |
| Start date | 2025-10-11 |
| NCT ID | NCT07359898 |
| Official listing | https://clinicaltrials.gov/study/NCT07359898 |