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European Study Evaluating the EMBLOK Embolic Protection System During TAVR

NCT03130491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-05

No results posted yet for this study

Summary

The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

Conditions

  • Aortic Valve Disease

Interventions

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR)

placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement

DEVICE

EMBLOK filter

Embolic Filter Protection System During TAVR

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Emblok, Inc.

    lead INDUSTRY

Principal Investigators

  • Azeem Latib, MD · Hospital San Raffaele

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2021-11-01
Completion
2022-01-28

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03130491 on ClinicalTrials.gov