Follow-up of the Navitor heart valve in people with aortic stenosis
Watches how safely the Navitor valve works in adults with aortic stenosis.
Key facts
- Who runs it
- Abbott Medical Devices
- Where
- London, Middlesbrough, Stoke-on-Trent, and Wolverhampton, United KingdomSee the 5 sitesAlso in 10 other countries, 44 sites
- Trial code
- Registry title
- Post-Market Clinical Follow Up Study With Navitor Valve
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 29 Sept 2023
- Expected to end
- Jun 2032
- Type of study
- Observational
- Treatments tested
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Record updated
- 10 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with aortic stenosis (a narrowed heart valve) who are planned to have a Navitor TAVI procedure. TAVI replaces the valve through a tube in a blood vessel.
- Age
- 18 Years to 100 Years
- Sex
- All
- Disease stage
- Aortic stenosis. The Heart Team must agree the Navitor TAVI procedure fits the approved use, and the procedure must be planned.
Main reasons for not taking part
- The Navitor TAVI System cannot be used for the patient under its Instructions for Use (IFU)
- Expected to live less than 12 months because of health problems not related to the heart
- Cannot have a CT scan or reacts to contrast dye, and this cannot be prevented with medicine beforehand
- Cannot take blood-thinning medicines or reacts to nitinol (nickel and titanium), and this cannot be prevented beforehand
- Blood vessel or valve shape that makes it hard or impossible to reach the valve
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure
- The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site
- The patient and the treating physician agree that the subject will return for all required post procedure follow up visits
Who cannot take part
- Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated
- Currently participating in an investigational drug or device study that may confound the results of this study
- Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions
- In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study
- Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)
- Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated
- Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United Kingdom
Also in 10 other countries, 44 sites
- Kings College HospitalLondon, United KingdomContact: Philip MacCarthyTaking people
- St Thomas HospitalLondon, United KingdomContact: Tiffany Patterson, DrTaking people
- James Cook University HospitalMiddlesbrough, United KingdomContact: Bart JanssensNo longer taking part
- Royal Stoke University HospitalStoke-on-Trent, United KingdomContact: Karim RatibTaking people
- New Cross HospitalWolverhampton, United KingdomContact: Shahzad MunirTaking people
About the trial
What the trial wants to find out
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
The group in the trial
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
The Navitor valve is available in five valve sizes to cover annulus diameters from 19 mm to 30 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and LG+.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
- Plain-language title
- Follow-up of the Navitor heart valve in people with aortic stenosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06008080, who can take part
- Record updated
- 10 July 2026