Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

NCT ID: NCT02349737

Last Updated: 2015-01-29

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

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Brief Summary

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Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

Detailed Description

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Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).

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 interferences of the ICD when BIA is done.

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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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Electromagnetic Interference

Exposure to BIA interference with the ICD

Intervention Type OTHER

Exposure to BIA interference with the ICD

Interventions

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Exposure to BIA interference with the ICD

Exposure to BIA interference with the ICD

Intervention Type OTHER

Other Intervention Names

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Study group

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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Philippe Meyer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Geneva

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Philippe Meyer, MD

Role: primary

+41223727225

References

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Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.

Reference Type BACKGROUND
PMID: 22452409 (View on PubMed)

Meyer P, Makhlouf AM, Mondouagne Engkolo LP, Trentaz F, Thibault R, Pichard C, Burri H. Safety of Bioelectrical Impedance Analysis in Patients Equipped With Implantable Cardioverter Defibrillators. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):981-985. doi: 10.1177/0148607116633823. Epub 2016 Feb 22.

Reference Type DERIVED
PMID: 26903305 (View on PubMed)

Other Identifiers

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Quality control study

Identifier Type: -

Identifier Source: org_study_id

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