Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs). No PVL-specific occluder device is available on the market. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.
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Number of subjects with sizing procedure success (efficacy outcome)
Timeframe: During index procedure
Incidence of a combined investigational device safety endpoint (safety outcome)
Timeframe: During index procedure