Safety of Cardiac Pacemakers in 1.5T Tesla MRI

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00336011
First received: June 9, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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


Condition Intervention
Heart Diseases
Device: Magnetic resonance imaging

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Estimated Enrollment: 75
Study Start Date: December 2002
Estimated Study Completion Date: January 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336011

Locations
Germany
University of Bonn, Department of Radiology
Bonn, NRW, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Medtronic
Investigators
Principal Investigator: Torsten Sommer, MD University of Bonn, Department of Radiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00336011     History of Changes
Other Study ID Numbers: 186/02
Study First Received: June 9, 2006
Last Updated: June 9, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
pacemaker
magnetic resonance imaging
safety

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014