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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00356239
Enrollment
25
Registered
2006-07-25
Start date
2006-07-31
Completion date
Unknown
Last updated
2007-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillators, Implantable, Heart Failure, Congestive

Keywords

Defibrillators, Implantable, Heart Failure, Congestive, Magnetic Resonance Imaging

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.

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Implantable Cardioverter Defibrillator * congestive heart failure * informed consent

Exclusion criteria

* Non-MRI-compatible implants

Countries

Germany

Contacts

Primary ContactTorsten Sommer, MD
t.sommer@uni-bonn.de+49-163-6113875
Backup ContactClaas P Naehle, MD
cp@naehle.net+49-178-4001619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026