International multicenter use of the Navitor/Navitor Vision transcatheter aortic valve

International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform (The Intensive Study)

This project will test how the Navitor/Navitor Vision transcatheter aortic valve performs in people with symptomatic severe native aortic stenosis treated at experienced centers across Europe and the UK.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Policlinico S. Donato (Academic / other)
• Locations: 1 site (San Donato Milanese, Lombardy)
• Trial ID: NCT07359898 on ClinicalTrials.gov

What this trial studies

INTENSIVE is a prospective, single-arm, investigator-initiated registry enrolling patients with symptomatic severe native aortic stenosis undergoing TAVI with the Navitor/Navitor Vision valve at up to 25 experienced centers in Europe and the UK. Data collection aligns with routine clinical care to capture real-world implant and outcome metrics across device sizes (23–35 mm) and delivery systems (FlexNav and loading systems). The protocol requires prior Heart Team determination and informed consent and includes sites with prior Portico or Navitor experience to ensure operator familiarity. The aim is to provide an objective benchmark of current TAVR practice and device performance outside of randomized controlled settings.

Who should consider this trial

Good fit: Ideal candidates are adults with symptomatic severe native aortic stenosis who have been recommended for TAVI with the Navitor/Navitor Vision system by their local Heart Team and can provide informed consent.

Not a fit: Patients with active sepsis or endocarditis, left ventricular or atrial thrombus, prohibitive vascular access issues, a non-calcified aortic annulus, pregnant or nursing individuals, or those requiring emergency surgery are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could show that the Navitor/Navitor Vision valve provides safe and effective valve replacement with reliable short- and mid-term outcomes in routine clinical practice.

How similar studies have performed: Previous experience with the first-generation Portico valve and other TAVR registries has demonstrated good outcomes, so this registry builds on existing, partially validated approaches rather than testing a wholly unproven concept.

Eligibility criteria

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 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

Where this trial is running

San Donato Milanese, Lombardy

• IRCCS Policlinico San Donato — San Donato Milanese, Lombardy, Italy (Recruiting)

Study contacts

• Study coordinator: Luca Testa, Principal Investigator

Conditions Severe Native Aortic Stenosis; Aortic Stenosis; TAVI; Navitor; Portico