Skip to main content
Clinical Trials/NCT00356239
NCT00356239
Unknown
N/A

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

University Hospital, Bonn1 site in 1 country25 target enrollmentJuly 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Defibrillators, Implantable
Sponsor
University Hospital, Bonn
Enrollment
25
Locations
1
Last Updated
19 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
TBD
Last Updated
19 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

  • Implantable Cardioverter Defibrillator
  • congestive heart failure
  • informed consent

Exclusion Criteria

  • Non-MRI-compatible implants

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

Loading locations...

Similar Trials