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Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

NCT05295628 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2025-08-06

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 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.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Disease
  • Aortic Valve Insufficiency
  • 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.

DEVICE

SENTINEL™ Cerebral Protection System

The SENTINEL CPS 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

Principal Investigators

  • Hemal Gada, MD · Heart and Vascular Institute, UPMC Pinnacle

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-05-06
Completion
2025-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05295628 on ClinicalTrials.gov