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Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

NCT02117414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2016-11-28

Study results available
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Summary

The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).

Conditions

  • Implantable Defibrillator

Interventions

DEVICE

MRI scan sequences of the head and chest regions

Non-diagnostic MRI scans

OTHER

Waiting Period Visit

Waiting period time will equate to 1 hour

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Michael R Gold, MD, PhD · Medical University of South Carolina

  • Emanuel Kanal, MD, FACR · University of Pittsburgh Medical Center, USA

  • Juerg Schwitter, MD · University Hospital Lausanne (CHUV), Switzerland

  • Torsten Sommer, MD · German Red Cross Hospital (DRK) Neuwied, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-01-31
Completion
2015-09-30

Countries

  • United States
  • Belgium
  • Canada
  • Chile
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Netherlands
  • Saudi Arabia
  • Sweden
  • Switzerland

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 NCT02117414 on ClinicalTrials.gov