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

NCT ID: NCT00356239

Last Updated: 2007-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Defibrillators, Implantable Heart Failure, Congestive

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Implantable Cardioverter Defibrillator
* congestive heart failure
* informed consent

Exclusion Criteria

* Non-MRI-compatible implants
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Principal Investigators

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Nikos Werner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn, Department of Cardiology

Locations

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University of Bonn, Department of Cardiology

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Torsten Sommer, MD

Role: CONTACT

[email protected]
+49-163-6113875

Claas P Naehle, MD

Role: CONTACT

[email protected]
+49-178-4001619

Facility Contacts

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Torsten Sommer, MD

Role: primary

[email protected]
+49-163-7113875

Claas P Naehle, MD

Role: backup

[email protected]
+49-178-4001619

References

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Naehle CP, Strach K, Thomas D, Meyer C, Linhart M, Bitaraf S, Litt H, Schwab JO, Schild H, Sommer T. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. 2009 Aug 4;54(6):549-55. doi: 10.1016/j.jacc.2009.04.050.

Reference Type DERIVED
PMID: 19643318 (View on PubMed)

Other Identifiers

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201/05

Identifier Type: -

Identifier Source: org_study_id