Micra Transcatheter Pacing System Continued Access Study Protocol

Not Applicable

Completed

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Complications	3 months post last follow up	Micra system and/or procedure-related complication rate

Secondary Outcome Measures

Name	Time	Method

Locations (29): Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Baptist Heart Specialists
🇺🇸
Jacksonville, Florida, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Michigan Heart
🇺🇸
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸
Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸
Saint Cloud, Minnesota, United States
Mid America Heart Institute
🇺🇸
Kansas City, Missouri, United States
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Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States