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Safety of Cardiac Pacemakers in 3 Tesla MRI

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ClinicalTrials.gov Identifier: NCT00356330
Recruitment Status : Unknown
Verified April 2007 by University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : July 26, 2006
Last Update Posted : April 11, 2007
Sponsor:
Information provided by:
University Hospital, Bonn

Brief Summary:
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Condition or disease
Heart Diseases

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-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.

Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.

In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.


Study Type : Observational
Enrollment : 75 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla




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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356330


Contacts
Contact: Torsten Sommer, MD +49-163-6113875 t.sommer@uni-bonn.de
Contact: Claas P Naehle, MD +49-178-4001619 cp@naehle.net

Locations
Germany
University of Bonn, Department of Radiology Recruiting
Bonn, NRW, Germany, 53127
Contact: Torsten Sommer, MD    +49-163-7113875    t.sommer@uni-bonn.de   
Contact: Claas P Naehle, MD    +49-178-4001619    cp@naehle.net   
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Torsten Sommer, MD University of Bonn, Department of Radiology

ClinicalTrials.gov Identifier: NCT00356330     History of Changes
Other Study ID Numbers: 116/06
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases