An observational study in Tachycardia Atrial, Atrial Fibrillation and Syncope, sponsored by Biotronik SE & Co. KG. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by Biotronik SE & Co. KG · Observational
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.
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 30 is below the median of 221 across 91 observational studies indexed under Syncope.
Browse Syncope studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient population consists of obese patients (BMI > 30 kg/m2) with an implantable cardiac monitor
Exclusion Criteria:
R-wave amplitude
R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30
Time frame: 3 month
Amount of 'noise burden'
Measurement of amount of 'noise burden' during the study period
Time frame: 3 month
P-wave visibility
Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation
Time frame: 1 month and 3 month
Incidence of arrhythmias
Assessment of the incidence of arrhythmias in obese patients implanted with an ICM
Time frame: 3 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Biotronik SE & Co. KG