The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR). The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems.
This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 560 subjects undergoing TAVR at up to 40 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days, and diffusion-weighted magnetic resonance imaging (DW-MRI) follow-up at 24 to 36 hours post-procedure.
Subject is ≥ 18 years of age.
Subject meets FDA approved indications for TAVR using an iliofemoral approach with a commercially approved transcatheter heart valve.
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to the index study procedure.
Subject agrees to comply with all protocol-specified procedures and assessments.
Subjects with hepatic failure (Child-Pugh class C).
Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
Subjects who have a planned treatment with any other investigational device or procedure during the study period.
Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.
Parallel
EMBLOK™ Embolic Protection System ("EMBLOK EPS")
DeviceThe EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
Primary Efficacy Endpoint
The primary efficacy endpoint is neuroprotection efficacy, determined by pair-wise comparisons among all subjects (Finkelstein-Schoenfeld \[FS\] method1) according to the following prespecified hierarchy of adverse outcomes: * Ischemic stroke (disabling or non-disabling) \[evaluated at 72 hours post-procedure\] * Total lesion volume by DW-MRI \[evaluated at 24-36 hours post-procedure\]
Primary Safety Endpoint
The primary safety endpoint is Major Adverse Events, defined as the composite of the following components at 30 days: * All-cause mortality * All stroke (disabling and non-disabling) * Acute kidney injury (Stage 3)
Combined Safety and Efficacy
Combined safety and efficacy endpoint is defined as a composite of the following VARC-2 defined components, evaluated post-procedure and in-hospital: * All-cause mortality * All stroke (disabling and non-disabling) and transient ischemic attack (TIA) * Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
Mortality (VARC-2 defined)
Mortality (VARC-2 defined), evaluated in-hospital, defined as All-cause mortality: * Cardiovascular mortality * Non-cardiovascular mortality
Neurological Events (VARC-2 and NeuroARC defined)
Neurological Events (VARC-2 and NeuroARC defined) * Stroke (subclassified as ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling) * TIA
Incidence of acute kidney injury (AKIN classification)
Incidence of acute kidney injury (AKIN classification), subclassified as stage 1, 2, or 3 Acute Kidney Injury (AKIN Classification) * AKI Stage 1 * AKI Stage 2 * AKI Stage 3
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Emblok, Inc.
Lead sponsor
Yale Cardiovascular Research Group
Collaborator
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