Advisa MRI Clinical Study

Advisa MRI™ System Clinical Investigation

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).

The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is 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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)