Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT04198220
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIO|STREAM.ICM Obesity
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: