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Post-Market Clinical Follow Up Study With Navitor Valve

Sponsor: Abbott Medical Devices

NCT ID: NCT06008080

View on ClinicalTrials.gov ↗

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.

Aortic Stenosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * 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. Exclusion Criteria: * Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU) * 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. * Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. * 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 * Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible

Where Is This Study? (6 UK sites)

Kings College Hospital

London, United Kingdom

Recruiting
Site contact (verified)

St. Thomas Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

James Cook University Hospital

Middlesbrough, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Recruiting
Site contact (verified)

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

New Cross Hospital

Wolverhampton, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Bart Janssens

Sponsor contact

CONTACT

+32471723201 bart.janssens@abbott.com

Alicia Kimber

Sponsor contact

CONTACT

+1 415-917-9696 alicia.kimber@abbott.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07