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ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation — ENVISION  

Aortic Valve Stenosis Clinical Trial

Official title:
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

Clinical Trial Summary

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

Clinical Trial Description

ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize approximately 1500 subjects at up to 95 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. Subjects in this clinical investigation will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05932615
Study type Interventional
Source Abbott Medical Devices
Contact Sara Scrivano
Phone 623-256-9821
Email sara.scrivano@abbott.com
Status Recruiting
Phase N/A
Start date March 19, 2024
Completion date April 2036
View Details
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