Micra Transcatheter Pacing System Post-Approval Registry

Study Overview
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Brief Summary
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Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in real-world clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

Detailed Description
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The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*. Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years. *Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.

Official Title
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Micra Transcatheter Pacing System Post-Approval Registry

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Micra Transcatheter Pacing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure Exclusion Criteria: Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with Micra System<br>Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry. | Device: Micra Transcatheter Pacing System<br>* The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.<br>* Other names: Micra TPS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute complication rate | To estimate acute complication rate related to the Micra system and/or implant procedure. | 30-days | 
| Long-term complication free survival | To estimate the chronic complication free survival rate of the Micra system. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacing impedance (ohms) and pacing threshold (volts) | Summary statistics of electrical performance 5-years post-implant measurements will be reported. | Up to 9 years | 
| Complications stratified by implant type | A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness. | Up to 9 years | 
| Estimate Micra System revision rate | Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported. | Up to 9 years | 
| Estimate System Longevity | Summary statistics regarding battery length will be reported. | Up to 9 years | 
| Confirm the rate response operation of the Micra system | Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873). | Approximately 2 years |