INTENSIVE
Research type
Research Study
Full title
International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform (The INTENSIVE Study)
IRAS ID
360086
Contact name
Saud Khawaja
Contact email
Sponsor organisation
IRCCS Policlinico San Donato
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 5 days
Research summary
The INTENSIVE Study is an international observational study designed to understand how a specific heart valve, called the Navitor/Navitor Vision Valve, performs in real-world clinical practice when used for a procedure known as Transcatheter Aortic Valve Implantation (TAVI). This study focuses on patients who have severe narrowing of their aortic valve (aortic stenosis) and, after comprehensive Heart Team evaluation, are scheduled to receive the Navitor/Navitor Vision Valve as part of their standard medical care. It is important to know that this is not a clinical trial testing a new treatment and participation is voluntary; patients will receive their usual care, and the study will simply collect information about their health and the valve's performance. We aim to include up to 1000 patients from approximately 25 hospitals across 5 European countries (Germany, Italy, Spain, UK, France). Subjects participating in the Study will be followed for a total of 5 years with data collected at baseline, procedure, prior to hospital discharge, and follow-up at 30 days, 12 months and annually thereafter up to 5 years.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
26/LO/0214
Date of REC Opinion
11 Mar 2026
REC opinion
Unfavourable Opinion