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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02536118
Registration number
NCT02536118
Ethics application status
Date submitted
17/08/2015
Date registered
31/08/2015
Date last updated
1/02/2024
Titles & IDs
Public title
Micra Transcatheter Pacing System Post-Approval Registry
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Scientific title
Micra Transcatheter Pacing System Post-Approval Registry
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Secondary ID [1]
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Micra Registry
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bradycardia
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Condition category
Condition code
Cardiovascular
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0
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0
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Other cardiovascular diseases
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Cardiovascular
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0
0
0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Micra Transcatheter Pacing System
Patients implanted with Micra System - Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Acute complication rate
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Assessment method [1]
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To estimate acute complication rate related to the Micra system and/or implant procedure.
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Timepoint [1]
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30-days
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Primary outcome [2]
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Long-term complication free survival
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Assessment method [2]
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To estimate the chronic complication free survival rate of the Micra system.
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Timepoint [2]
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9 years
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Secondary outcome [1]
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Pacing impedance (ohms) and pacing threshold (volts)
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Assessment method [1]
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Summary statistics of electrical performance 5-years post-implant measurements will be reported.
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Timepoint [1]
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Up to 9 years
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Secondary outcome [2]
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Complications stratified by implant type
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 9 years
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Secondary outcome [3]
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Estimate Micra System revision rate
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Assessment method [3]
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Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
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Timepoint [3]
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Up to 9 years
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Secondary outcome [4]
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Estimate System Longevity
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Assessment method [4]
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Summary statistics regarding battery length will be reported.
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Timepoint [4]
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Up to 9 years
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Secondary outcome [5]
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Confirm the rate response operation of the Micra system
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Assessment method [5]
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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).
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Timepoint [5]
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Approximately 2 years
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose
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Selection
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Timing
Prospective
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
3100
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Recruitment in Australia
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Funding & Sponsors
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Commercial sector/Industry
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Name
Medtronic
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02536118
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Contacts
Principal investigator
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Micra Registry Manager
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Address
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Medtronic
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02536118
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