Micra Transcatheter Pacing System Post-Approval Registry

Medtronic

Status: Active, not recruiting

Conditions: Bradycardia

Treatments: Device: Micra Transcatheter Pacing System

Study type: Observational

Funder types: Industry

Identifiers

NCT02536118

Micra Registry

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,100 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,100 participants in 1 patient group

Patients implanted with Micra System

Description:

Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.

Treatment:

Device: Micra Transcatheter Pacing System