BIO|STREAM.ICM Obesity

Biotronik

Status: Completed

Conditions: Bradycardia; Syncope; Atrial Fibrillation; Cryptogenic Stroke; Tachycardia Atrial

Study type: Observational

Funder types: Industry

Identifiers

NCT04198220

HS064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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