RESTORE: Re-do TAVR for TAVR Failure
RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE)
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Clinical Trial Information
Trial Contact: Ngo, George M.; Harms, Gabrielle T; Marquart, Vashnie; Rodriguez, Jessica M
Trial Phone: 3218439657 ; 4077012135 ; 321-843-1037 ; 3218413270
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IRB No: S25.022.01
Protocol Abbrev: RESTORE
Principal Investigator:
Age Group: Adult
Secondary Protocol No: MDT23040EVR015- Version 2.0
Treatment: Redo TAVR for the treatment of BVF affecting TAVs
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT06557798
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Objective
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 -
Key Eligibility
Subjects with symptomatic heart disease due to bioprosthetic valve failure (BVF) affecting TAVs and requiring redo Transcatheter Aortic Valve Replacement (TAVR). All devices in this study will be used per the intended use approved by the local regulatory agency.