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Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla

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:
NCT00356239
First received: July 24, 2006
Last updated: April 9, 2007
Last verified: April 2007
History of Changes
  Purpose

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.


Condition
Defibrillators, Implantable
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bonn:

Estimated Enrollment: 25
Study Start Date: July 2006
Detailed Description:

The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Implantable Cardioverter Defibrillator
  • congestive heart failure
  • informed consent

Exclusion Criteria:

  • Non-MRI-compatible implants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356239

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 Cardiology 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: Nikos Werner, MD University of Bonn, Department of Cardiology
  More Information

No publications provided by University Hospital, Bonn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00356239     History of Changes
Other Study ID Numbers: 201/05
Study First Received: July 24, 2006
Last Updated: April 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
Defibrillators, Implantable
Heart Failure, Congestive
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013