Safety and Performance Study of the Reliance 4-Front Lead

Inclusion Criteria

• Willing and capable of providing informed consent
• Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
• Subjects planned to be implanted with the RELIANCE 4-FRONT Active Fixation Lead
• Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
• Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria

• Known or suspected sensitivity to Dexamethasone Acetate (DXA)
• Mechanical tricuspid heart valve
• Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (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 RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
• RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
• Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
• Currently on the active heart transplant list
• Documented life expectancy of less than 12 months
• Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
• Currently requiring chronic dialysis