Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336011
Status:
COMPLETED
Last Update Posted:
2006-06-12
First Post:
2006-06-09
Brief Title:
Safety of Cardiac Pacemakers in 15T Tesla MRI
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 15 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 15T Tesla
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers
Detailed Description:
The presence of a cardiac pacemaker PM is currently considered an absolute contraindication to MR imaging and most patients with PM are excluded from having MRI In 2002 there were approximately 24 million patients in the US with cardiac PM and this number is growing by 80000 annually A previous study has shown that MRI is indicated in 17 of all patients with pacemakers within 12 months of device placement 1 demonstrating the need for a practical and safe approach for performing MRI on PM patients
The aim of this study is to develop a strategy for safe performance of MR imaging at 15T which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax restriction of specific absorption rate SAR values to minimize the risk of lead heating and PM reprogramming to avoid interference from time varying gradient fields The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds and performing a 3-month follow-up to evaluate long-term effects
The aim of this study is to develop a strategy for safe performance of MR imaging at 15T which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax restriction of specific absorption rate SAR values to minimize the risk of lead heating and PM reprogramming to avoid interference from time varying gradient fields The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds and performing a 3-month follow-up to evaluate long-term effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None