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

Conditions

• Aortic Valve Disease
• Aortic Valve Stenosis
• Heart Disease Structural Disorder
• Heart Valve Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Navitor Transcatheter Aortic Valve Implantation (TAVI) System — DEVICE
  TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
• Any Commercially Available Transcatheter Aortic Valve (CAV) System — DEVICE
  TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

Study Details

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. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

Key Dates

Start date

Mar 15, 2024

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2036

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
  TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
• Active Comparator: Any Commercially Available Transcatheter Aortic Valve System (CAV)
  TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

Primary Outcome Measure

Composite of all-cause mortality or all stroke [ Time Frame: At 12 months post-procedure ]

Locations (67)

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