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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
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 it's running

• IRCCS Policlinico San Donato
  San Donato Milanese, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Luca Testa, Principal Investigator
• Email: luca.testa@grupposandonato.it
• Phone: 00390252774980

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.