Micra AV Transcatheter Pacing System Post-Approval Registry (Micra AV PAS)
|ClinicalTrials.gov Identifier: NCT04253184|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 11, 2020
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.
|Condition or disease||Intervention/treatment|
|Bradycardia||Drug: Micra AV Transcatheter Pacing System|
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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||750 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Micra AV Transcatheter Pacing System Post-Approval Registry|
|Actual Study Start Date :||February 8, 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
- Drug: Micra 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.
- Rate of pacemaker syndrome [ Time Frame: 3 years ]To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
- Acute complication rate [ Time Frame: 30 days ]To estimate the acute major complication rate related to the Micra AV system and/or procedure.
- Long-term complication rate [ Time Frame: 3 years ]To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.
- AV Synchrony Loss [ Time Frame: 3 years ]To characterize the rate and severity of adverse events potentially related to AV synchrony loss
- System and Procedure Releated AEs [ Time Frame: 3 years ]Summarize Micra AV system or procedure related adverse events
- Implant Characteristics [ Time Frame: Up to 3 years ]Characterize the implant procedure
- Electrical Performance [ Time Frame: 3 years ]Characterize electrical performance over time
- A4 Amplitude [ Time Frame: 3 years ]Characterize A4 amplitude over time
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253184
|Contact: Micra AV Registry Manageremail@example.com|