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Neuroprotection in Patients Undergoing Aortic Valve Replacement

NCT02389894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2019-04-29

Study results available
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Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Conditions

  • Aortic Stenosis
  • Brain Infarction
  • Cerebrovascular Accident
  • Stroke

Interventions

DEVICE

Embol-X Embolic Protection Device

per the manufacturer's instructions for use (IFU).

DEVICE

CardioGard Cannula

CardioGard Cannula, per the manufacturer's instructions for use (IFU).

Sponsors & Collaborators

Principal Investigators

  • Annetine C Gelijns, PhD · Icahn School of Medicine at Mount Sinai

  • Richard Weisel, MD · Toronto General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT02389894 on ClinicalTrials.gov