RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE).
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
open
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Clinical Trials Website Interest FormBrief Summary
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).
Eligibility
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