Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protec… (NCT07129421) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
560 participantsStarted 2025-10-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation.
Exclusion criteria
✕. 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.
What they're measuring
1
Primary Efficacy Endpoint
Timeframe: Evaluated at 72 hours post-procedure (TAVR)
2
Primary Safety Endpoint
Timeframe: Evaluated at 30-day post-procedure (TAVR) follow-up visit
✕. Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure.
✕. Subject requires an urgent or emergent TAVR procedure.
✕. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula, or on dialysis).
✕. Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit (baseline mRS ≥3).