Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

BIO|MASTER.BIOMONITOR III

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.

Study Overview

• Status: Completed
• Conditions: Syncope; Atrial Fibrillation (AF); Cryptogenic Stroke; Tachyarrhythmia
• Intervention / Treatment: Device: BIOMONITOR III and BIOMONITOR IIIm

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Auchenflower, Australia
    • GenesisCare Wesley
  • Bundaberg, Australia
    • GenesisCare Bundaberg
  • Doncaster East, Australia
    • GenesisCare Doncaster
  • Garran, Australia
    • Canberra Heart Rhythm Clinic
  • Randwick, Australia
    • Prince of Wales Hospital
  • Woolloongabba, Australia
    • Princess Alexandra Hospital
• Austria
  • Linz, Austria
    • Kepler Universitätsklinikum
  • Wels, Austria
    • Klinikum Wels-Grieskirchen
  • Wien, Austria
    • Allgemeines Krankenhaus der Stadt Wien (AKH)
• Denmark
  • Viborg, Denmark
    • Regionshospitalet Viborg
• Germany
  • Bad Neustadt An Der Saale, Germany
    • Rhön-Klinikum Campus Bad Neustadt
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW
  • Dresden, Germany
    • Städtisches Klinikum Dresden-Friedrichstadt
  • Dresden, Germany
    • Universitätsklinik an der Technischen Universität Dresden
  • Gera, Germany
    • SRH Wald-Klinikum Gera GmbH
  • Giessen, Germany
    • Universitätsklinikum Gießen und Marburg GmbH (UKGM)
  • Greifswald, Germany
    • Ernst-Moritz-Arndt-Universität Greifswald
  • Leipzig, Germany
    • Klinikum St. Georg gGmbH
  • Leverkusen, Germany
    • Klinikum Leverkusen Service GmbH
  • Lünen, Germany
    • St.-Marien-Hospital GmbH
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
• Spain
  • León, Spain
    • Hospital del Bierzo
  • Ourense, Spain
    • Complejo Hospitalario de Ourense
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla
• Switzerland
  • Lausanne, Switzerland
    • CHUV - Centre Hospitalier Universitaire Vaudoise
  • Lugano, Switzerland
    • Fondazione Cardiocentro Ticino
  • Saint Gallen, Switzerland
    • Kantonsspital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is at high risk of developing a clinically important cardiac arrhythmia; or
• Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
• Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
• Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
• Patient is able to understand the nature of the study and able to provide written informed consent.
• Patient is willing and able to perform all follow-up visits at the investigational site.
• Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

• Patient is implanted with an ICD or pacemaker.
• Patient is pregnant or breast-feeding.
• Patient is less than 18 years old.
• Patient's life-expectancy is less than 12 months.
• Patient is participating in another interventional clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: all patients	Device: BIOMONITOR III and BIOMONITOR IIIm; Insertion of BIOMONITOR III or BIOMONITOR IIIm; three scheduled in-office follow-ups; 48-hour Holter ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SADE-free Rate Until the 3-month Follow-up	SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R-wave Amplitude	The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.	10 days to 4 weeks after insertion; 3-months
Noise Burden	The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.	10 days to 4 weeks after insertion; 3-months
Assessment of P-wave Visibility	The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.	10 days to 4 weeks after insertion; 3-months
SADE-free Rate Until the 12-month Follow-up	The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.	12-months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Thomas Deneke, Prof. Dr., RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Neurobehavioral Manifestations; Stroke; Consciousness Disorders; Unconsciousness; Ischemic Stroke; Atrial Fibrillation; Tachycardia; Syncope
• Other Study ID Numbers: BA109

Drug and device information, study documents

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