BIO|STREAM.ICM Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Bradycardia; Syncope; Cryptogenic Stroke; Tachycardia Atrial

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Castrovillari, Italy, 87012
    • Ospedale Civile Ferrari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population consists of obese patients (BMI > 30 kg/m2) with an implantable cardiac monitor

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R-wave amplitude	R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of 'noise burden'	Measurement of amount of 'noise burden' during the study period	3 month
P-wave visibility	Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation	1 month and 3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of arrhythmias	Assessment of the incidence of arrhythmias in obese patients implanted with an ICM	3 month

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Giovanni Bisignani, Dr., Ospedale Civile Ferrari

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Atrial Fibrillation; Syncope; BIOMONITOR; BIOMONITOR III; Cryptogenic stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Stroke; Unconsciousness; Consciousness Disorders; Obesity; Ischemic Stroke; Atrial Fibrillation; Bradycardia; Tachycardia; Syncope
• Other Study ID Numbers: HS064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No