This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety of Cardiac Pacemakers in 3 Tesla MRI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by University Hospital, Bonn.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Bonn Identifier:
First received: July 25, 2006
Last updated: April 9, 2007
Last verified: April 2007
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Heart Diseases

Study Type: Observational
Study Design: 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

Further study details as provided by University Hospital, Bonn:

Estimated Enrollment: 75
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.


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

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
  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 identifier: NCT00356330

Contact: Torsten Sommer, MD +49-163-6113875
Contact: Claas P Naehle, MD +49-178-4001619

University of Bonn, Department of Radiology Recruiting
Bonn, NRW, Germany, 53127
Contact: Torsten Sommer, MD    +49-163-7113875   
Contact: Claas P Naehle, MD    +49-178-4001619   
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Torsten Sommer, MD University of Bonn, Department of Radiology
  More Information Identifier: NCT00356330     History of Changes
Other Study ID Numbers: 116/06
Study First Received: July 25, 2006
Last Updated: April 9, 2007

Keywords provided by University Hospital, Bonn:
magnetic resonance imaging

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on August 18, 2017