Bradycardia
Conditions
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.
Interventions
DEVICEMicra 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.
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term complication free survival | 9 years | To estimate the chronic complication free survival rate of the Micra system. |
| Acute complication rate | 30-days | To estimate acute complication rate related to the Micra system and/or implant procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| Pacing impedance (ohms) and pacing threshold (volts) | Up to 9 years | Summary statistics of electrical performance 5-years post-implant measurements will be reported. |
Countries
Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORMicra Registry Manager
Medtronic
Outcome results
None listed