This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
328
Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie
Munich, Bavaria, Germany
RECRUITINGTotal new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI)
Time frame: Day 2-4 post-procedure
Number of new cerebral lesions detected by MRI
Time frame: Day 2-4 post-procedure
Occurrence of clinical stroke and/or neurocognitive dysfunction as assessed by neurological and neurocognitive assessments
Time frame: Day 2-4 post-procedure; 6 months post-procedure
Postoperative Outcome according to the VARC 2 criteria
Time frame: from operation until hospital discharge; 30-days, 6-months
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