RESTORE

Full Clinical Trial Name

RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE)

Clinical Trial

  • Heart and Vascular
  • Surgery

Patient Type

Adult
Doctor(s) running this study
Dzanan Ramic, MD
Location(s):
Call 610-402-9543
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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).

Description

The RESTORE study is a prospective, non-randomized, multi-center, post-market study of redo TAVR in patients with bioprosthetic valve failure (BVF). Approximately 225 subjects at 100 sites in the U.S. and Canada will participate in this study. The commercially available Medtronic and Edwards transcatheter aortic valves (TAVs) devices will be used to replace a participant’s existing TAV that has worn out or is no longer working effectively.

All consented subjects will undergo follow-up for up to 5 years. For each subject data will be collected at baseline, pre- and post-procedure, discharge, 30 days, 1-year, and annually thereafter. 

Eligibility

Inclusion Criteria

Prospective subjects must meet all the following inclusion criteria to be eligible for participation:

• bioprosthetic valve failure (BVF) of a transcatheter aortic valve (TAV) (either Medtronic or Edwards) requiring redo TAVR

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Doctor(s) running this study