Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

University Hospitals (UH)

Status: Completed

Conditions: Electromagnetic Interference

Treatments: Other: Study group

Study type: Interventional

Funder types: Other

Identifiers

NCT02330900

14-245

Details and patient eligibility

About

Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)

Full description

Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implantation with a wireless-enabled ICD

Exclusion criteria

• Age <18yrs
• inability to sign an informed consent
• pacemaker dependancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Study group

No Intervention group

Description:

Evaluation of interference

Treatment:

Other: Study group