Evaluation of the Navitor Valve for Aortic Stenosis

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

This study evaluates the safety and performance of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System in patients with aortic stenosis in a real-world setting. It aims to assess the long-term durability of the valve and gather data on its effectiveness post-implantation. Patients will be monitored through follow-up visits to ensure comprehensive data collection and analysis of outcomes.

Why it matters

Who can join: the full rules

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 it's running

• Royal Adelaide Hospital
  Adelaide, Australia Recruiting
• Royal Hobart Hospital
  Hobart, Australia Recruiting
• The Alfred Hospital
  Melbourne, Australia Recruiting
• Institute Cardio. Paris-Sud - Institut Jacques Cartier
  Massy, France Recruiting
• Clinique du Millénaire
  Montpellier, France Recruiting
• Mutualiste Montsouris
  Paris, France Recruiting

Study contacts

• Principal investigator: Alper Öner, MD — Universitätsmedizin Rostock, Germany
• Study coordinator: Bart Janssens
• Email: bart.janssens@abbott.com
• Phone: +32471723201

Similar studies

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

• Exercise and nutrition support before and after TAVI for older adults with aortic stenosis

  This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.

  Recruiting University Hospital of Ferrara · Ferrara, FE · NCT07895719

• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

  This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Istanbul · NCT07794436

• Systematic 14-day ambulatory heart monitoring after TAVI

  After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.

  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

• Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis

  This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.

  Recruiting at 4 sites Azienda Ospedaliera "Sant'Andrea" · Bologna and 4 other locations · NCT07620925

• TAVI without on-site heart surgery: can selected centers do it safely?

  This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.

  Recruiting at 10 sites University Hospital of Ferrara · Andria and 10 other locations · NCT07604402

• Willem AI for early detection of aortic stenosis from a 12‑lead ECG

  This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.

  Recruiting at 2 sites Idoven 1903 S.L. · Bonn and 1 other locations · NCT07479992

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.