Safety of Cardiac Pacemakers in 3 Tesla MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00356330
First received: July 25, 2006
Last updated: April 9, 2007
Last verified: April 2007
  Purpose

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


Condition
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla

Resource links provided by NLM:


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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356330     History of Changes
Other Study ID Numbers: 116/06
Study First Received: July 25, 2006
Last Updated: April 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014