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Completed

NCT Number: NCT04253184

Micra AV Transcatheter Pacing System Post-Approval Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micra AV Transcatheter Pacing System

Device

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.

Primary outcomes

  1. Rate of pacemaker syndrome

    Time frame: After 3 years of Follow Up

    To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.

Secondary outcomes

  1. Acute complication rate

    Time frame: After 30 days of Follow Up

    To estimate the acute major complication rate related to the Micra AV system and/or procedure.

  2. Long-term complication rate

    Time frame: After 3 years of Follow up

    To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.

Other outcomes

  1. AV Synchrony Loss

    Time frame: After 3 years of Follow up

    To characterize the rate and severity of adverse events potentially related to AV synchrony loss

  2. System and Procedure Related Adverse Events

    Time frame: After 3 years of Follow up

    Summarize Micra AV system or procedure related adverse events

  3. Implant Characteristics

    Time frame: Up to 3 years of Follow Up

    Characterize the implant procedure

  4. Electrical Performance

    Time frame: After 3 years of Follow up

    Characterize electrical performance over time

  5. A4 Amplitude

    Time frame: After 3 years of Follow up

    Characterize A4 amplitude over time

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Acronym: Micra AV PAS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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