Status:
UNKNOWN
Safety of Cardiac Pacemakers in 3 Tesla MRI
Lead Sponsor:
University Hospital, Bonn
Conditions:
Heart Diseases
Eligibility:
All Genders
Brief Summary
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.
Detailed Description
Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk...
Eligibility Criteria
Inclusion
- Urgent need for an MRI examination
- 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
- History of ventricular tachycardia (VT) or ventricular fibrillation
- Unstable angina
- Myocardial infarction within the previous 3 months
- Cardiothoracic surgery within the previous 3 months
- Presence of an abdominal pacemaker with lead length \> 70 cm
- Presence of MRI incompatible bioimplants or other MRI incompatible materials
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00356330
Last Update
April 11 2007
Active Locations (1)
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1
University of Bonn, Department of Radiology
Bonn, North Rhine-Westphalia, Germany, 53127