Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
484 participants
INTERVENTIONAL
2007-02-28
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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MRI group
The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Pacer and leads
Magnetic Resonance Imaging (MRI) scan
One hour MRI scan on the head and lower back.
Control group
The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.
Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Pacer and leads
Interventions
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Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Pacer and leads
Magnetic Resonance Imaging (MRI) scan
One hour MRI scan on the head and lower back.
Eligibility Criteria
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Inclusion Criteria
* Subject available for follow-up at study center for length of study.
* Subject able and willing to undergo elective MRI scanning without sedation.
Exclusion Criteria
* Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
* Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
* Subject who intends to participate in another clinical study during this clinical study.
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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EMRI SureScan Clinical Study Team
Role: STUDY_CHAIR
Medtronic
Locations
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Redwood City, California, United States
Salinas, California, United States
Orlando, Florida, United States
Peachtree City, Georgia, United States
Des Moines, Iowa, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Mineola, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Erie, Pennsylvania, United States
Knoxville, Tennessee, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Graz, , Austria
Linz, , Austria
Liège, , Belgium
Mons, , Belgium
Calgary, Alberta, Canada
Victoria, British Columbia, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Prague, , Czechia
Rouen, , France
Bad Nauheim, , Germany
Bonn, , Germany
Dortmund, , Germany
Dresden, , Germany
Essen, , Germany
Göttingen, , Germany
Hamburg, , Germany
Marburg, , Germany
München, , Germany
Ulm, , Germany
Asti, , Italy
Pescia, , Italy
Pietra Ligure, , Italy
Viterbo, , Italy
Amsterdam, , Netherlands
Nieuwegein, , Netherlands
Zurich, , Switzerland
London, , United Kingdom
Countries
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References
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Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.
Other Identifiers
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212
Identifier Type: -
Identifier Source: org_study_id
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