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Micra Transcatheter Pacing System Post-Approval Registry

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ClinicalTrials.gov Identifier: NCT02536118
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:

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.


Condition or disease Intervention/treatment
Bradycardia Device: Micra Transcatheter Pacing System

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Years
Official Title: Micra Transcatheter Pacing System Post-Approval Registry
Actual Study Start Date : July 2015
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Group/Cohort Intervention/treatment
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Device: Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Other Names:
  • Micra
  • Micra TPS




Primary Outcome Measures :
  1. Acute complication rate [ Time Frame: 30-days ]
    To estimate acute complication rate related to the Micra system and/or implant procedure.

  2. Long-term complication free survival [ Time Frame: 9 years ]
    To estimate the chronic complication free survival rate of the Micra system.


Secondary Outcome Measures :
  1. Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 9 years ]
    Summary statistics of electrical performance 5-years post-implant measurements will be reported.

  2. Complications stratified by implant type [ Time Frame: Up to 9 years ]
    A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.

  3. Estimate Micra System revision rate [ Time Frame: Up to 9 years ]
    Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.

  4. Estimate System Longevity [ Time Frame: Up to 9 years ]
    Summary statistics regarding battery length will be reported.

  5. Confirm the rate response operation of the Micra system [ Time Frame: Approximately 2 years ]
    Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).


Other Outcome Measures:
  1. Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment [ Time Frame: Up to 9 years ]
    Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients intended to be implanted with a Micra system are eligible for enrollment and all patients must be consented prior to the Micra system implant. As such, only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section).

All patients enrolled and successfully implanted with a Micra system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent, or unless the patient is participating in an acute performance sub-study of the Micra Registry. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536118


Contacts
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Contact: Micra Registry Manager rs.productsurveillanceregistry@medtronic.com

  Show 156 Study Locations
Sponsors and Collaborators
Medtronic
Investigators
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Study Director: Micra Registry Manager Medtronic

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT02536118     History of Changes
Other Study ID Numbers: Micra Registry
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes