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
269 participants
INTERVENTIONAL
2010-06-30
2013-03-31
Brief Summary
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Detailed Description
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Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MRI group
Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Medtronic CapSureFix MRI™ active fixation MRI lead
The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.
Control group
Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.
Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Medtronic CapSureFix MRI™ active fixation MRI lead
The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.
Interventions
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Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Medtronic CapSureFix MRI™ active fixation MRI lead
The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are able to undergo a pectoral implant
* Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
* Subjects who are geographically stable and available for follow-up at the study center for the length of the study
Exclusion Criteria
* Subjects with a history of significant tricuspid valvular disease
* Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated
* Subjects who require a legally authorized representative to obtain consent
* Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
* Subjects who are immediate candidates for an ICD
* Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
* Subjects with previously implanted active medical devices
* Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g. non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys)
* Subjects with medical conditions that preclude the testing required by the protocol or limit study participation
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
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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Advisa MRI Trial Leader
Role: STUDY_CHAIR
Medtronic
Locations
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Central Coast Cardiology
Salinas, California, United States
Mid Florida Cardiology
Orlando, Florida, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Mid America Heart Institute
Kansas City, Missouri, United States
Raleigh Cardiology Associates
Raleigh, North Carolina, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Greenville Hospital System
Greenville, South Carolina, United States
Cardiology Associates of East Tennesee
Knoxville, Tennessee, United States
Baylor Heart & Vascular Hosptial
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
St. George Hospital
Kogarah, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Adelaide Cardiology
Adelaide, South Australia, Australia
Epworth
Richmond, Victoria, Australia
Landesklinikum St. Pölten
Sankt Pölten, , Austria
Hôpital Saint-Joseph
Gilly, , Belgium
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
CHRU Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU Hôpiteaux de Rouen
Rouen, , France
Centre Hospitalier Universitaire Saint Étienne
Saint-Etienne, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität
Rostock, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Semmelweis Egyetem AOK
Budapest, , Hungary
Rambam Health Care Campus
Haifa, , Israel
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy
Azienda Complesso Ospedaliero San Filippo Neri
Roma, , Italy
Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
Amsterdam, , Netherlands
VU Medisch Centrum
Amsterdam, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
HagaZiekenhuis - Locatie Leyweg
The Hague, , Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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References
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Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.
Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Toth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.
Other Identifiers
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AdvisaMRI
Identifier Type: -
Identifier Source: org_study_id