Clinical trial
Micra AV Transcatheter Pacing System Post-Approval Registry
Name
Micra AV PAS
Description
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.
Trial arms
Trial start
2020-02-08
Estimated PCD
2025-04-01
Trial end
2025-04-01
Status
Active (not recruiting)
Treatment
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.
Size
802
Primary endpoint
Rate of pacemaker syndrome
3 years
Eligibility criteria
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 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 802, 'type': 'ACTUAL'}}
Updated at
2024-02-01
1 organization
2 products
1 indication
Organization
MedtronicProduct
Micra AVIndication
Slow heart rate