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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02536118




Registration number
NCT02536118
Ethics application status
Date submitted
17/08/2015
Date registered
31/08/2015
Date last updated
5/02/2020

Titles & IDs
Public title
Micra Transcatheter Pacing System Post-Approval Registry
Scientific title
Micra Transcatheter Pacing System Post-Approval Registry
Secondary ID [1] 0 0
Micra Registry
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute complication rate - To estimate acute complication rate related to the Micra system and/or implant procedure.
Timepoint [1] 0 0
30-days
Primary outcome [2] 0 0
Long-term complication free survival - To estimate the chronic complication free survival rate of the Micra system.
Timepoint [2] 0 0
9 years
Secondary outcome [1] 0 0
Pacing impedance (ohms) and pacing threshold (volts) - Summary statistics of electrical performance 5-years post-implant measurements will be reported.
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [2] 0 0
Complications stratified by implant type - 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.
Timepoint [2] 0 0
Up to 9 years
Secondary outcome [3] 0 0
Estimate Micra System revision rate - Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
Timepoint [3] 0 0
Up to 9 years
Secondary outcome [4] 0 0
Estimate System Longevity - Summary statistics regarding battery length will be reported.
Timepoint [4] 0 0
Up to 9 years
Secondary outcome [5] 0 0
Confirm the rate response operation of the Micra system - 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).
Timepoint [5] 0 0
Approximately 2 years

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02536118
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Micra Registry Manager
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Micra Registry Manager
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
rs.productsurveillanceregistry@medtronic.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02536118