At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System (device)
- How long the study runs
- Study runs about 105 months (dates as stated)
- About the drug or intervention
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System — device: Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
- Patient visit burden
- Not specified by the sponsor
In plain English
This study follows people with aortic stenosis (a narrowing of the heart's aortic valve) who are having a Navitor TAVI procedure. TAVI stands for transcatheter aortic valve implantation, where a replacement valve is fitted using a thin tube without open-heart surgery. The sponsor is Abbott Medical Devices, and the aim is to check how well the valve works after it has been approved for use.
Who can take part
- Your heart team has decided you are suitable for a Navitor TAVI procedure under the current approved use.
- You have been told about the study and have given written informed consent, approved by the ethics committee at your hospital.
- You and your doctor agree you will come back for all the required follow-up visits after the procedure.
Who may not be able to
- You are not suitable for the Navitor TAVI system according to its current instructions for use.
- You are expected to live less than 12 months from giving consent, due to health problems not related to your heart.
- In the researcher's view, a medical, social or psychological condition could stop you taking part, doing the tests, or attending follow-up visits, or could affect the study's integrity.
- You cannot have a CT (computed tomography) scan or tolerate contrast dye (the liquid injected for scans), and this cannot be managed with pre-treatment medicine.
- You cannot tolerate antiplatelet or anticoagulation medicines (blood-thinning medicines), or nitinol (an alloy of nickel and titanium used in the valve), and this cannot be managed with pre-treatment medicine.
- You are currently taking part in another study of an investigational drug or device that could affect this study's results.
- Your body's shape or blood vessels make it difficult or impossible to insert the tube and reach the aortic valve.
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about the number and timing of follow-up visits and how long the study lasts, but you must be willing and able to attend all required follow-up visits.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 1,000
- Started
- 2023-09-29
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for aortic stenosis
- • Clinical study - 1,000 participants
- • Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with aortic stenosis
Where?
- • London - Kings College Hospital
- • London - St. Thomas Hospital
- • Middlesbrough - James Cook University Hospital
- • Stoke-on-Trent - Royal Stoke University Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
More detail
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ post procedure follow up visits
What the study is looking for
- ✓Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a...
- ✓The patient and the treating physician agree that the subject will return for all required post procedure follow up...
Who cannot take part
- ✗Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)
- ✗Life expectancy \< 12 months from the time of agreement to take part due to non-heart co-morbid conditions.
- ✗Known safety concern for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately...
- ✗Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be...
- ✗Currently participating in an investigational drug or device study that may confound the results of this study
See the full criteria
Where Is This Study? (6 UK sites)
Kings College Hospital
London, United Kingdom
St. Thomas Hospital
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
How to Get in Touch
Bart Janssens
Sponsor contactCONTACT
Alicia Kimber
Sponsor contactCONTACT
