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

Abbott

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Study type: Observational

Funder types: Industry

Identifiers

NCT06008080

ABT-CIP-10476

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Description:

The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and large.

Treatment:

Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System