NCT04788888

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

Detailed description

The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality. This trial will also evaluate the safety and effectiveness of the Navitor valve in a valve-in-valve application.

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Navitor Transcatheter Aortic valve and FlexNav Delivery system	Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system.

Timeline

• Start date: 2021-07-13
• Primary completion: 2025-01-02
• Completion: 2036-02-28
• First posted: 2021-03-09
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

37 sites across 11 countries: Australia, Austria, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study