Micra Transcatheter Pacing System Post-Approval Registry
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 1/20/2019 |
Start Date: | July 2015 |
End Date: | August 2026 |
Contact: | Micra Registry Manager |
Email: | rs.productsurveillanceregistry@medtronic.com |
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the
Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world"
clinical practice, following commercial release.
The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world"
clinical practice, following commercial release.
The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
The Micra Registry is a global, prospective, observational, multi-site registry. Patients
enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years
post-implant or until registry closure, patient death, patient exit from the registry (i.e.,
withdrawal of consent), or unless patient is participating in an acute performance sub-study
of the Micra Registry*.
Enrolled patients will have scheduled follow-up visits at least annually or as prompted by
reportable adverse events; however, all Micra system follow-up patient visits are to be
reported. Therefore, if more frequent scheduled visits occur per a provider's standard care
practice, those visits are reported. The total estimated registry duration is 11 years.
*Patients contributing to an acute performance sub-study of the Micra Registry do not
contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum
9-year) patient follow-up period.
enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years
post-implant or until registry closure, patient death, patient exit from the registry (i.e.,
withdrawal of consent), or unless patient is participating in an acute performance sub-study
of the Micra Registry*.
Enrolled patients will have scheduled follow-up visits at least annually or as prompted by
reportable adverse events; however, all Micra system follow-up patient visits are to be
reported. Therefore, if more frequent scheduled visits occur per a provider's standard care
practice, those visits are reported. The total estimated registry duration is 11 years.
*Patients contributing to an acute performance sub-study of the Micra Registry do not
contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum
9-year) patient follow-up period.
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 Transcatheter Pacing System
and must be enrolled prior to the TPS 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
We found this trial at
53
sites
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