Post-Market Clinical Follow Up Study With Navitor Valve

Aortic Stenosis Clinical Trial

— VISTA  

Official title:

VISTA Study (Navitor Post-Market Clinical Follow Up Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008080
• Other study ID #: ABT-CIP-10476
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: December 2030

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: Bart Janssens
• Phone: +32471723201
• Email: bart.janssens[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Description:

The VISTA Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2030
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• The patient is scheduled 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:

• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System

Locations

Country	Name	City	State
France	Clinique du Millénaire	Montpellier
France	Mutualiste Montsouris	Paris
France	Clinique Pasteur Toulouse	Toulouse
Germany	Deutsches Herzzentrum der Charité	Berlin
Germany	St Johannes Hospital Dortmund	Dortmund
Germany	UKE Hamburg	Hamburg
Germany	University Hospital Rostock	Rostock
Italy	Centro Cardiologico Monzino	Milano
Italy	Ospedale San Raffaele	Milano
Portugal	Hospital de Santa Cruz	Carnaxide
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Switzerland	KS St. Gallen / USZ	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

France,  Germany,  Italy,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality at 30 days post-TAVI procedure	Death from all causes at 30 days post-TAVI procedure	30 days post index procedure
Primary	Moderate or greater paravalvular leak at 30 days post-TAVI procedure	Assessment of paravalvular leak at 30 days post-TAVI procedure	30 days post index procedure