Electromagnetic Interference Clinical Trial
Official title:
Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices
NCT number | NCT03264222 |
Other study ID # | GER-EP-017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | October 31, 2018 |
Verified date | July 2021 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.
Status | Completed |
Enrollment | 379 |
Est. completion date | October 31, 2018 |
Est. primary completion date | July 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - implantable pacemaker or defibrillator in situ Exclusion Criteria: - malfunction of implantable pacemaker or defibrillator - low battery voltage of implanted cardiac electronic device |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum München | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen | Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electromagnetic interference | Occurrence of electromagnetic interference | 10 minutes |
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