Safety of Cardiac Pacemakers in 1.5T Tesla MRI

June 9, 2006 updated by: University Hospital, Bonn

Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 1,5 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 1.5T Tesla)

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.

Study Type

Observational

Enrollment

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bonn, NRW, Germany, 53127
        • University of Bonn, Department of Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Urgent need for an MRI examination
  • Presence of a Medtronic PM system manufactured between 1993 and 2004

  • Stable pacemaker physical parameters

    • Battery voltage > 2.7 V
    • Battery impedance < 2000 Ohm
    • Battery estimated remaining lifetime > 6 months
    • Lead impedances 200-2000 Ohm

  • Stable pacing parameters

    • Pacing capture threshold <2.5V at a pulse duration of 0.4ms
    • Sensing > 5mV
  • Minimum 3 months since pacemaker and lead implantation

Exclusion Criteria:

  • PM system manufacturer other than Medtronic
  • History of ventricular tachycardia (VT) or ventricular fibrillation
  • Unstable angina
  • Myocardial infarction within the previous 3 months
  • Cardiothoracic surgery within the previous 3 months
  • Complete atrioventricular block

  • Absolute pacemaker dependence

    • Heart rate < 40 bpm or
    • Heart rate < 60 bpm producing neurological symptoms
  • Presence of an abdominal pacemaker with lead length > 70 cm
  • Presence of MRI incompatible bioimplants or other MRI incompatible materials
  • Request for an MR examination of the chest, including the heart, breasts and thoracic spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

Medtronic

Investigators

  • Principal Investigator: Torsten Sommer, MD, University of Bonn, Department of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

June 12, 2006

Last Update Submitted That Met QC Criteria

June 9, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 186/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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