ImageReady(TM) MR Conditional Pacing System Clinical Study

Inclusion criteria

• Subject must have the ImageReady System as their initial (de novo) pacing system implant
• Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
• Subject is able and willing to undergo an MRI scan without intravenous sedation
• Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

• Subject has or has had any pacing or ICD system implants
• Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
• Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
• Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
• Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
• Subject has a mechanical tricuspid heart valve
• Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:

• Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);
• SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);
• Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations
• Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
• Subject is currently on the active heart transplant list
• Subject has documented life expectancy of less than 12 months
• Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)
• Subjects currently requiring dialysis