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Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR

NCT07129421 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

  • AORTIC VALVE DISEASES
  • Aortic Valve Stenosis and/or Insufficiency
  • Aortic Valve Regurgitation
  • Aortic Valve Replacement

Interventions

DEVICE

EMBLOK™ Embolic Protection System ("EMBLOK EPS")

The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Emblok, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2027-01-31
Completion
2027-03-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07129421 on ClinicalTrials.gov