REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Purpose

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Condition

  • Aortic Stenosis

Eligibility

Eligible Ages
Between 18 Years and 105 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion Criteria

  • BVF due solely to paravalvular regurgitation - Active endocarditis - Untreated acute valve thrombosis - Life-expectancy less than 1-year - Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable - Participating in another study that may influence the outcome of this study

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV) Subjects will receive either a Medtronic TAV or Edwards TAV
  • Device: Medtronic TAV
    Medtronic TAV where commercially available
  • Device: Edwards TAV
    Edwards TAV where commercially available.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Joanna Mandinova

More Details

Status
Recruiting
Sponsor
Medtronic Cardiovascular

Study Contact

RESTORE Study Clinical Team
763 514 4000
RS.RESTORESTUDY@medtronic.com

Detailed Description

Primary Objectives: - To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs - To determine the factors which are associated with the acute and long-term outcomes of redo TAVR