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NCT00356239 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

Official title:
Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00356239
Other study ID # 201/05
Secondary ID
Status Recruiting
Phase N/A
First received July 24, 2006
Last updated April 9, 2007
Start date July 2006

Study information
Verified date April 2007
Source University Hospital, Bonn
Contact Torsten Sommer, MD
Phone +49-163-6113875
Email t.sommer@uni-bonn.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Implantable Cardioverter Defibrillator

- congestive heart failure

- informed consent

Exclusion Criteria:

- Non-MRI-compatible implants

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University of Bonn, Department of Cardiology Bonn NRW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

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