Micra Transcatheter Pacing System Continued Access Study Protocol

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Medtronic Micra Transcatheter Pacing System Continued Access Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Micra Pacemaker Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micra Pacemaker Implant<br>Micra Pacemaker Implant | Device: Micra Pacemaker Implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Micra system and/or procedure-related complication rate | 3 months post last follow up |