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Navitor Transcatheter Aortic Valve Implantation (TAVI) System for Aortic Valve Disease (ENVISION Trial)

N/A
Recruiting
Led By Bassem Chehab, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months post-procedure
Awards & highlights

ENVISION 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.

Eligible Conditions
  • Aortic Valve Disease
  • Aortic Valve Stenosis
  • Heart Valve Disease
  • Heart Disease

ENVISION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of all-cause mortality or all stroke

ENVISION Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Navitor Transcatheter Aortic Valve Implantation (TAVI) SystemExperimental Treatment1 Intervention
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Group II: Any Commercially Available Transcatheter Aortic Valve System (CAV)Active Control1 Intervention
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
639 Previous Clinical Trials
403,431 Total Patients Enrolled
7 Trials studying Aortic Valve Disease
3,105 Patients Enrolled for Aortic Valve Disease
Azeem Azeem, MDStudy ChairMontefiore Medical Center
Bassem Chehab, MDPrincipal InvestigatorCardiovascular Research Institute of Kansas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
2024. "ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05932615.
All > Knoxville
~1000 spots leftby Apr 2027
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