Clinical Trial

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Active, Not Recruiting
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Summary
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. 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 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-03-15; most recent amendment 2025-08-01.
Status change: Recruiting → Active, Not Recruiting 2025-06-18
Status change: Not Yet Recruiting → Recruiting 2023-11-07
Trial Details
NCT Number NCT05295628
Lead Sponsor Emblok, Inc.
Collaborators: Yale Cardiovascular Research Group
Conditions Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
Enrollment 532 participants
Start Date 2023-10-17
Primary Completion 2025-05-06 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-06