Micra Transcatheter Pacing System Continued Access Study Protocol

The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow
controlled access of the Micra system when used as intended. All subjects enrolled in the
Micra CA Study will be prospectively followed from implant, at 6-month intervals until study
closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac
stimulation systems will have additional follow ups.

Inclusion Criteria:

- Subject or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements

- Subject meets Class I or ll indication for implantation of single chamber ventricular
pacemaker and is intended to be implanted with a Micra System

- Subject able and accessible for follow-up per study requirements

- Subject is at least 18 years of age

- Patient is not enrolled in a concurrent drug and/or device study that may confound
registry result.

Exclusion Criteria:

- Subject has had an acute myocardial infraction (AMI) within 30 days of implant

- Subject has implantation of neurostimulator or any other chronically implanted device
which uses current in the body

- Subject with mechanical tricuspid valve, implanted vena cava filter, or left
ventricular assist device (LVAD)

- Subjects who are morbidly obese and physician believes telemetry communication of ≤5
inches (12.5 cm) could not be obtained with programmer head.

- Subject who femoral venous anatomy is unable to accommodate a 23 French introducer
sheath or implant on the right side of the heart (for example due to obstructions or
sever tortuosity) in the opinion of the implanter

- Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy

- Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated

- Subjects with life expectancy less than 12-months

- Subject is enrolled in a concurrent drug and/or device study that may confound CA
study results