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Clinical Trials/NCT00336011
NCT00336011
Completed
Not Applicable

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)

University Hospital, Bonn1 site in 1 country75 target enrollmentDecember 2002
ConditionsHeart Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
University Hospital, Bonn
Enrollment
75
Locations
1
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2002
End Date
January 2006
Last Updated
19 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bonn

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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