International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform (The Intensive Study)
Status: Recruiting
Location: See location...
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• Subject is of legal age for consent in the host country.
• 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.
Locations
Other Locations
Italy
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Luca Testa, Principal Investigator
luca.testa@grupposandonato.it
00390252774980
Time Frame
Start Date:2025-10-11
Estimated Completion Date:2031-10
Participants
Target number of participants:1000
Treatments
Aortic Stenosis Patients
This Study will enroll subjects of all genders who have symptomatic, severe AS, either in native or in a surgical bioprosthetic valve and are indicated for TAVI implantation. The latter can also be predominantly regurgitant to be suitable for enrolment. Subjects must meet all general eligibility criteria for the TAVI procedure and provide written informed consent prior to sites collecting any clinical data for this Study.~The operative risk determination of study candidates will be done by the local heart team. The assessment of surgical risk will include the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Risk Calculator score and/or EuroSCORE II, indices of frailty, and comorbidities not captured by risk calculators, as described below, and current TAVI practice guidelines.