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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT02536118 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Micra Transcatheter Pacing System Post-Approval Registry
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Scientific title:
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Micra Transcatheter Pacing System Post-Approval Registry |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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3100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02536118 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Greece
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Hungary
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Iceland
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Israel
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Italy
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Japan
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Kuwait
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Russian Federation
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Saudi Arabia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Arab Emirates
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United Kingdom
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United States
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Contacts
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Name:
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Micra Registry Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medtronic |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bradycardia
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Intervention(s)
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Device: Micra Transcatheter Pacing System
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Primary Outcome(s)
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Long-term complication free survival
[Time Frame: 9 years]
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Acute complication rate
[Time Frame: 30-days]
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Secondary Outcome(s)
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Confirm the rate response operation of the Micra system
[Time Frame: Approximately 2 years]
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Estimate System Longevity
[Time Frame: Up to 9 years]
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Pacing impedance (ohms) and pacing threshold (volts)
[Time Frame: Up to 9 years]
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Complications stratified by implant type
[Time Frame: Up to 9 years]
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Estimate Micra System revision rate
[Time Frame: Up to 9 years]
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Secondary ID(s)
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Micra Registry
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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