Electromagnetic Interference Clinical Trial
Official title:
Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
NCT number | NCT03508128 |
Other study ID # | EdwardH |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 4, 2018 |
Est. completion date | August 18, 2018 |
Verified date | August 2018 |
Source | Edward-Elmhurst Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).
Status | Completed |
Enrollment | 7 |
Est. completion date | August 18, 2018 |
Est. primary completion date | August 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - subjects with an implanted Micra pacemaker who required a surgical procedure Exclusion Criteria: - no Micra pacemaker |
Country | Name | City | State |
---|---|---|---|
United States | EdwardElmhurst Healthcare | Naperville | Illinois |
Lead Sponsor | Collaborator |
---|---|
Edward-Elmhurst Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EMI | Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms | up to 6 months next postop interrogation | |
Secondary | Device reset | Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms | up to 6 months next postop interrogation |
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