Safety and Performance Study of the INGEVITY Lead

The objective of this study is to gather data to establish the safety, performance and
effectiveness of the INGEVITY pace/ sense leads

Inclusion Criteria:

- Subject is willing and capable of providing informed consent

- Subject has a Class I or II indication for implantation of a single(VVI (R) only) or
dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC
guidelines

- Subject is 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

- 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 a 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

- Subjects with documented permanent or persistent AF where the physician intends to
implant dual chamber pulse generator (single chamber VVIR pulse generators in these
subjects is 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 INGEVITY Lead implant

- Subjects currently requiring dialysis