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

N/A
Waitlist Available
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
No Placebo-Only Group

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 Disease
  • Heart Valve Disease
  • Valvular Heart Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of all-cause mortality or all stroke

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
650 Previous Clinical Trials
409,866 Total Patients Enrolled
7 Trials studying Aortic Valve Disease
3,100 Patients Enrolled for Aortic Valve Disease
Azeem Latib, MDStudy ChairMontefiore Medical Center
7 Previous Clinical Trials
333,548 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
28 Patients Enrolled for Aortic Valve Disease
Vinny PodichettyStudy DirectorAbbott Structural Heart
9 Previous Clinical Trials
3,956 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
358 Patients Enrolled for Aortic Valve Disease
~1000 spots leftby Apr 2027
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