Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study

Exclusion Criteria

• •1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
• •2. Subject is enrolled in any other concurrent study without prior written approval from BSC, 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 RALLY X4 Study (i.e. should not cause additional or missed visits);
• •* RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
• •* Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable
• •3. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure
• •4. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.
• •5. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center
• •6. Subject does not anticipate being a resident of the area for the scheduled duration of the trial
• •7. Subject's physician does not allow participation
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