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BIO|STREAM.ICM Obesity

NCT ID: NCT04198220

Last Updated: 2021-10-22

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-17

Study Completion Date

2021-09-01

Brief Summary

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The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

Detailed Description

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This submodule of the BIO\|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI \>30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.

Conditions

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Tachycardia Atrial Atrial Fibrillation Syncope Bradycardia Cryptogenic Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is already enrolled in the BIO\|STREAM.ICM registry
* Patient BMI \> 30

Exclusion Criteria

* Patient clinically indicated for or already implanted with another cardiac active device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Bisignani, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile Ferrari

Locations

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Ospedale Civile Ferrari

Castrovillari, , Italy

Site Status

Countries

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Italy

References

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Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.

Reference Type DERIVED
PMID: 37025684 (View on PubMed)

Other Identifiers

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HS064

Identifier Type: -

Identifier Source: org_study_id