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Clinical Trials/NCT04198220
NCT04198220CompletedNot Applicable

BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry

Biotronik SE & Co. KG1 site in 1 country30 target enrollmentStarted: September 17, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
R-wave amplitude
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

R-wave amplitude

Time Frame: 3 month

R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30

Secondary Outcomes

  • Amount of 'noise burden'(3 month)
  • P-wave visibility(1 month and 3 month)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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