BIO|STREAM.ICM Obesity

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198220
• Other study ID #: HS064
• Status: Completed
• Start date: September 17, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia
• Cryptogenic Stroke
• Ischemic Stroke
• Obesity
• Syncope
• Tachycardia
• Tachycardia Atrial

Locations

Country	Name	City	State
Italy	Ospedale Civile Ferrari	Castrovillari

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of arrhythmias	Assessment of the incidence of arrhythmias in obese patients implanted with an ICM	3 month
Primary	R-wave amplitude	R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30	3 month
Secondary	Amount of 'noise burden'	Measurement of amount of 'noise burden' during the study period	3 month
Secondary	P-wave visibility	Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation	1 month and 3 month