Micra Transcatheter Pacing System Post-Approval Registry
- Conditions
- Bradycardia
- Interventions
- Device: Micra Transcatheter Pacing System
- Registration Number
- NCT02536118
- Lead Sponsor
- Medtronic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients implanted with Micra System Micra Transcatheter Pacing System Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
- Primary Outcome Measures
Name Time Method Acute complication rate 30-days To estimate acute complication rate related to the Micra system and/or implant procedure.
Long-term complication free survival 9 years To estimate the chronic complication free survival rate of the Micra system.
- Secondary Outcome Measures
Name Time Method Estimate Micra System revision rate Up to 9 years Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
Estimate System Longevity Up to 9 years Summary statistics regarding battery length will be reported.
Pacing impedance (ohms) and pacing threshold (volts) Up to 9 years Summary statistics of electrical performance 5-years post-implant measurements will be reported.
Complications stratified by implant type Up to 9 years 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.
Confirm the rate response operation of the Micra system Approximately 2 years 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).