Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

NCT ID: NCT02330900

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Electromagnetic Interference

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

Evaluation of interference

Group Type NO_INTERVENTION

Study group

Intervention Type OTHER

Exposure to cell phone interference of the ICD

Interventions

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Study group

Exposure to cell phone interference of the ICD

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Implantation with a wireless-enabled ICD

Exclusion Criteria

* Age \<18yrs
* inability to sign an informed consent
* pacemaker dependancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Haran Burri, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haran Burri, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

References

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Burri H, Mondouagne Engkolo LP, Dayal N, Etemadi A, Makhlouf AM, Stettler C, Trentaz F. Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators. Europace. 2016 May;18(5):726-31. doi: 10.1093/europace/euv374. Epub 2016 Feb 8.

Reference Type DERIVED
PMID: 26857191 (View on PubMed)

Other Identifiers

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14-245

Identifier Type: -

Identifier Source: org_study_id

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