Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

CapSureFix® Novus Model 5076 Lead MRI Study

The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.

Inclusion Criteria:

• Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
• Subjects who are able to undergo a pectoral implant
• Subjects who:
• are receiving an IPG for the first time, OR
• are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads
• Subjects who are able and willing to undergo elective MRI scanning without sedation
• Subjects who are geographically stable and available for follow-up at the study site 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 1.0mg dexamethasone acetate may be contraindicated.
• Subjects who require a legally authorized representative to obtain consent.
• Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads
• Subjects who are immediate candidates for an ICD.
• Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.
• Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).
• 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).