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

(ENVISION Trial)

Recruiting at62 trial locations

Overseen by Ibrahim Sultan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bassem Chehab, MD

Principal Investigator

Cardiovascular Research Institute of Kansas

Ibrahim Sultan, MD

Principal Investigator

The University of Pittsburgh Medical Center

Barathi Sethuraman

Principal Investigator

Abbott Structural Heart

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Azeem Azeem, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

You are at an intermediate risk of overall surgical mortality, estimated to be between 3-8% within 30 days.

Key

You have a low estimated risk of overall surgical mortality at 30 days, taking into account your STS Risk Score and NYHA Functional Classification

Treatment Details

Participant Groups

Group I: Navitor Transcatheter Aortic Valve Implantation (TAVI) System Experimental Treatment 1 Intervention

TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Group II: Any Commercially Available Transcatheter Aortic Valve System (CAV) Active Control 1 Intervention

TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business