Actively Recruiting
Post-Market Clinical Follow Up Study With Navitor Valve
Led by Abbott Medical Devices · Updated on 2025-06-06
1000
Participants Needed
35
Research Sites
426 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
CONDITIONS
Official Title
Post-Market Clinical Follow Up Study With Navitor Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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/EC 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.
You will not qualify if you...
- Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
- Life expectancy less than 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Royal Hobart Hospital
Hobart, Australia
Actively Recruiting
2
Clinique du Millénaire
Montpellier, France
Actively Recruiting
3
Mutualiste Montsouris
Paris, France
Actively Recruiting
4
CHRU Hopital de Pontchaillou
Rennes, France
Actively Recruiting
5
Clinique Pasteur Toulouse
Toulouse, France
Actively Recruiting
6
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany
Actively Recruiting
7
Deutsches Herzzentrum der Charité
Berlin, Germany
Actively Recruiting
8
St Johannes Hospital Dortmund
Dortmund, Germany
Actively Recruiting
9
Kliniken der Friedrich-Alexander-Universitat
Erlangen, Germany
Actively Recruiting
10
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, Germany
Actively Recruiting
11
UKE Hamburg
Hamburg, Germany
Actively Recruiting
12
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Actively Recruiting
13
Deutsches Herzzentrum München des Freistaates Bayern
München, Germany
Actively Recruiting
14
University Hospital Rostock
Rostock, Germany
Actively Recruiting
15
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
16
Az. Osp. Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
17
Casa di Cura Pineta Grande
Castel Volturno, Italy
Actively Recruiting
18
Centro Cardiologico Monzino
Milan, Italy
Actively Recruiting
19
Ospedale San Raffaele - Cardiac
Milan, Italy
Actively Recruiting
20
Policlinico San Donato
San Donato Milanese, Italy
Actively Recruiting
21
Onze Lieve Vrouw Gasthuis
Amsterdam, Netherlands
Actively Recruiting
22
ULS de Lisboa Ocidental
Carnaxide, Portugal
Actively Recruiting
23
Hospital Universitario de Badajoz
Badajoz, Spain
Active, Not Recruiting
24
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
25
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Actively Recruiting
26
Hospital General Juan Ramon Jimenez
Huelva, Spain
Actively Recruiting
27
Hospital de Gran Canaria Doctor Negrín
Las Palmas, Spain
Actively Recruiting
28
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Actively Recruiting
29
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
30
Sahlgrenska University Hospital - Gothenburg
Gothenburg, Sweden
Actively Recruiting
31
KS St. Gallen / USZ
Sankt Gallen, Switzerland
Actively Recruiting
32
Kings College Hospital
London, United Kingdom
Actively Recruiting
33
James Cook University Hospital
Middlesbrough, United Kingdom
Active, Not Recruiting
34
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Actively Recruiting
35
New Cross Hospital
Wolverhampton, United Kingdom
Actively Recruiting
Research Team
B
Bart Janssens
CONTACT
A
Alicia Kimber
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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