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Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

NCT01755143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2015-07-20

Study results available
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Summary

The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.

Conditions

  • Magnetic Resonance Imaging (MRI)
  • Cardiac Pacing

Interventions

OTHER

Magnetic Resonance Imaging scan sequences of the head, neck, and chest

DEVICE

Pacemaker System

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Australia
  • Austria
  • Belgium
  • Chile
  • China
  • Colombia
  • Germany
  • Hong Kong
  • India
  • Netherlands
  • Portugal
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Switzerland
  • Taiwan

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 NCT01755143 on ClinicalTrials.gov