Advisa MRI Clinical Study

Completed · Not applicable

Conditions studied: Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial

In brief

The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

Key facts

Study ID

NCT01110915

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

269

Starts

2010-06-01

Expected to finish

2013-03-01

Last updated by the study team

2013-04-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
• 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

You may not qualify if…

• Subjects with a mechanical tricuspid heart valve
• 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
• Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)

Where it is running

• 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

Full record on ClinicalTrials.gov

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