Micra Transcatheter Pacing System Post-Approval Registry
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|ClinicalTrials.gov Identifier: NCT02536118|
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 18, 2019
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.
|Condition or disease||Intervention/treatment|
|Bradycardia||Device: Micra Transcatheter Pacing System|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3100 participants|
|Target Follow-Up Duration:||9 Years|
|Official Title:||Micra Transcatheter Pacing System Post-Approval Registry|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2026|
|Estimated Study Completion Date :||August 2026|
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Device: Micra Transcatheter Pacing System
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.
- Acute complication rate [ Time Frame: 30-days ]To estimate acute complication rate related to the Micra system and/or implant procedure.
- Long-term complication free survival [ Time Frame: 9 years ]To estimate the chronic complication free survival rate of the Micra system.
- Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 9 years ]Summary statistics of electrical performance 5-years post-implant measurements will be reported.
- Complications stratified by implant type [ Time Frame: 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.
- Estimate Micra System revision rate [ Time Frame: 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 [ Time Frame: Up to 9 years ]Summary statistics regarding battery length will be reported.
- Confirm the rate response operation of the Micra system [ Time Frame: 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).
- Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment [ Time Frame: Up to 9 years ]Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536118
|Contact: Micra Registry Manageremail@example.com|
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|Study Director:||Micra Registry Manager||Medtronic|