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

Status: Recruiting

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

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:
Valve dysfunction of a TAV (either Medtronic or Edwards) requiring redo TAVR
Exclusion Criteria:

• Valve dysfunction solely due to a paravalvular leak (a gap between the artificial heart valve and natural heart tissue)
• Active endocarditis- a serious infection of the heart
• Life expectancy less than one year
• Participation in another research study that may influence the outcome of this study
Interventions:

Drug/Device: Commercially available Medtronic and Edwards Transcatheter Aortic Valves (TAV) with the TAV-in-TAV

Conditions:

Patients with symptomatic heart disease due to bioprosthetic valve failure (BVF) affecting TAVs and requiring redo Transcatheter Aortic Valve Replacement (TAVR).

Keywords:

bioprosthetic valve failure, BVF, TAV-in-TAV, TAVR, Transcatheter Aortic Valve Replacement

Contact(s): Veronica Gorden - vgorden1@hfhs.org
Principal Investigator: Pedro Engel
Principal Investigator ID: pengel1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov

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