B-50 | Full-Body Embolic Protection During Transcatheter Aortic Valve Replacement: The Protect the Head-to-Head Study, a Pivotal, Randomized Study Comparing the Emboliner Embolic Protection Catheter to the Sentinel CPS

The PROTECTED TAVR trial failed to demonstrate reduction in all stroke with the Sentinel Cerebral Protection System but suggested a incidence of disabling stroke. CPS is first-generation device that protects two three cerebral vessels leaving left vertebral unprotected and does not provide full body protection allowing debris flow into descending aorta. Emboliner Embolic Catheter (Emboline, Inc. Santa Cruz, CA) provides full-body embolic using cylindrical nitinol filter aortic arch an expanding access port for passage devices. It includes inflatable dilator integrated 9.5 Fr sheath rapid deployment contralateral femoral 6 lumen angiographic pigtail catheter. captures aorta, providing protection. Protect Head-to-Head study (H2H) prospective, 1:1 randomized, open-label, 500-subject safety & efficacy comparing subjects undergoing Edwards or Medtronic valves. primary combined endpoint 30-day MACCE rate (all death, stage 3 AKI, VARC-2 defined), secondary endpoints include defined (Non-Inferiority) number particles captured >150 μm (Superiority). Up 20 sites will participate Brazil, Germany US at least 50% from sites. Technical success be determined by independent core lab, capture analysis conducted histopathology lab committee review adjudicate site reported data. Enrollment start Q1 2023 anticipated finish Q2 2024. Early feasibility studies demonstrated >150μm subjects, fast preparation ease use, technical as well compatibility self- balloon-expanding systems. We present early results Emboline rational pivotal randomized trial.