Bradycardia
Conditions
Brief summary
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
Detailed description
The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent). Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years
Interventions
DEVICEMicra AV Transcatheter Pacing System
The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.
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 AV Transcatheter Pacing System and must be enrolled prior to the 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 |
|---|---|---|
| Rate of pacemaker syndrome | After 3 years of Follow Up | To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute complication rate | After 30 days of Follow Up | To estimate the acute major complication rate related to the Micra AV system and/or procedure. |
| Long-term complication rate | After 3 years of Follow up | To estimate the 3-year major complication rate related to the Micra AV system and/or procedure. |
Countries
Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Malaysia, Netherlands, Norway, Portugal, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed