Status:
COMPLETED
Safety of Cardiac Pacemakers in 1.5T Tesla MRI
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Medtronic
Conditions:
Heart Diseases
Eligibility:
All Genders
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
OBSERVATIONAL
End Date :
January 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00336011
Start Date
December 1 2002
End Date
January 1 2006
Last Update
June 12 2006
Active Locations (1)
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1
University of Bonn, Department of Radiology
Bonn, North Rhine-Westphalia, Germany, 53127