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Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.
The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
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Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.
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Data sourced from clinicaltrials.gov
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