Safety and Performance Study of the Siello S Pacing Lead

Inclusion Criteria:

- Candidate for de novo implantation of a BIOTRONIK pacemaker system, including one or
two Siello S leads. Candidate meets recommendation for pacemaker system implant put
forth by guidelines of relevant professional societies.

- Able to understand the nature of the study and provide informed consent.

- Available for follow-up visits on a regular basis at the investigational site for the
expected 5 years of follow-up.

- Age greater than or equal to 18 years.

Exclusion Criteria:

- Enrolled in any other investigational clinical study.

- Currently implanted with a pacemaker or ICD device.

- Planned cardiac surgical procedures or interventional measures within the next 6
months.

- Expected to receive a heart transplant within 1 year.

- Life expectancy less than 1 year.

- Presence of another life-threatening, underlying illness separate from their cardiac
disorder.

- Pregnant at the time of enrollment.