Micra AV Transcatheter Pacing System Post-Approval Registry

  • STATUS
    Recruiting
  • participants needed
    750
  • sponsor
    Medtronic
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Updated on 19 February 2024
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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.

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

Details
Condition Arrhythmia, Arrhythmia, Bradycardia
Age 100years or below
Treatment Micra AV Transcatheter Pacing System
Clinical Study IdentifierNCT04253184
SponsorMedtronic
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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