Micra Transcatheter Pacing System Continued Access Study Protocol
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
Condition or disease
Device: Micra Pacemaker Implant
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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