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

NCT05932615 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-05-08

No results posted yet for this study

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.

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.

Conditions

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

Interventions

DEVICE

Navitor Transcatheter Aortic Valve Implantation (TAVI) System

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

DEVICE

Any Commercially Available Transcatheter Aortic Valve (CAV) System

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Haresh Sachanandani · Abbott Structural Heart

  • Michael Reardon, MD · The Methodist Hospital Research Institute

  • Azeem Azeem, MD · Montefiore Medical Center

  • Bassem Chehab, MD · Ascension Via Christi Hospitals

  • Ibrahim Sultan, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2027-04-30
Completion
2036-04-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Israel
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932615 on ClinicalTrials.gov