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