China Micra Transcatheter Pacing Study

All study sites will be in China. Subjects successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. The overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.

Inclusion criteria

• Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and China guideline.
• Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
• Subjects who are at least 18 years of age.

Exclusion criteria

• Subject has an existing or prior pacemaker, ICD or CRT device implant.
• Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
• Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
• Subjects with a 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.
• Subjects whose 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 severe tortuosity) in the opinion of the implanter.
• Subjects who are considered as unable to tolerate an urgent sternotomy.
• Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
• Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
• Subjects with a life expectancy of less than 12-months.
• Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
• Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
• Subjects with exclusion criteria required by local law (age or other).
• Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.