FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: 32a686790f13b719512945eae361cfc61c180164
First added on: May 21, 2024