International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform

NCT07359898 | Recruiting

• 1 other identifier: INTENSIVE CET 264-2025
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Native Aortic Stenosis

Keywords

Aortic Stenosis; TAVI; Navitor; Portico

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  The primary endpoint is all-cause mortality at 12 months after the index Navitor/Navitor Vision implantation procedure.

  12 months

Secondary Outcomes (3)

• Valve Academic Research Consortium 3 (VARC-3) event definitions

  30 days and 12 months

• Valve Academic Research Consortium 3 (VARC-3) event definitions

  30 days, 3 months, and 12 months

• Valve Academic Research Consortium 3 (VARC-3) event definitions

  30 days, 12 months and annually through 5 years

Study Arms (1)

Aortic Stenosis Patients

This Study will enroll subjects of all genders who have symptomatic severe AS, either in a native valve or in a surgical bioprosthetic valve, and who have an indication for TAVI. The latter may also be predominantly regurgitant and remain suitable for enrolment. Subjects must meet all general eligibility criteria for the TAVI procedure and provide written informed consent before sites collect 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This Study will enroll subjects of all genders who have symptomatic severe AS, either in a native valve or in a surgical bioprosthetic valve, and who have an indication for TAVI. The latter may also be predominantly regurgitant and remain suitable for enrolment.

You may qualify if:

• Subject is referred to undergo TAVI with a Navitor/Navitor Vision valve according to the local Heart Team. The Heart Team determines the indication for TAVI with Navitor/Navitor Vision before possible enrolment and independently of 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.

You may not qualify if:

• Pregnant or nursing subjects
• Need for emergency surgery for any reason
• Contraindications to Navitor/Navitor Vision TAVI according to the IFU:
• Any sepsis, including active endocarditis
• Any evidence of left ventricular or atrial thrombus
• Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible
• Non-calcified aortic annulus
• Any leaflet configuration other than tricuspid
• Inability to tolerate antiplatelet/anticoagulant therapy
• Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority
• Individuals who are unable to read or write

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• Meditrial SrL: collaborator
• Abbott: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Luca Testa, Principal Investigator

CONTACT

00390252774980; luca.testa@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 22, 2026
• Study Start: October 11, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2031
• Last Updated: July 24, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)