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Sponsored by: |
University Hospital, Bonn |
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Information provided by: | University Hospital, Bonn |
ClinicalTrials.gov Identifier: | NCT00356239 |
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.
Condition |
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Defibrillators, Implantable Heart Failure, Congestive |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators |
Estimated Enrollment: | 25 |
Study Start Date: | July 2006 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Torsten Sommer, MD | +49-163-6113875 | t.sommer@uni-bonn.de |
Contact: Claas P Naehle, MD | +49-178-4001619 | cp@naehle.net |
Germany, NRW | |
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 |
Principal Investigator: | Nikos Werner, MD | University of Bonn, Department of Cardiology |
Study ID Numbers: | 201/05 |
Study First Received: | July 24, 2006 |
Last Updated: | April 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00356239 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Defibrillators, Implantable Heart Failure, Congestive Magnetic Resonance Imaging |
Heart Failure Heart Diseases Ataxia-Telangiectasia Ataxia Telangiectasia |
Cardiovascular Diseases |