ImageReady(TM) MR Conditional Pacing System Clinical Study

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