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Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation

Radboud University Medical Center · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation. The main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach: * Is associated with less clinically relevant access site-related bleeding complications. * Is associated with a shorter time to mobilization after TAVI. * Is associated with a shorter duration of hospitalization. * Has the same early safety outcomes at 30 days post-TAVI. Participants will be subject to the usual care surrounding a TAVI procedure but will also will be asked to fill out two questionnaires before and after TAVI: * Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) * Lower Extremity Functional Scale (LEFS) Researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.
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