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

NCT04025710 | Completed Results

• 1 other identifier: BA109
• Study Type: interventional
• Target: 167
• Locations: 5 countries
• Sites: 24

Brief Summary

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.

Conditions

Tachyarrhythmia; Atrial Fibrillation (AF); Syncope; Cryptogenic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• R-wave Amplitude

  10 days to 4 weeks after insertion; 3-months

• Noise Burden

  10 days to 4 weeks after insertion; 3-months

• Assessment of P-wave Visibility

  10 days to 4 weeks after insertion; 3-months

• SADE-free Rate Until the 12-month Follow-up

  12-months

Study Arms (1)

all patients

OTHER

Device: BIOMONITOR III and BIOMONITOR IIIm

Interventions

BIOMONITOR III and BIOMONITOR IIIm DEVICE

* Insertion of BIOMONITOR III or BIOMONITOR IIIm * three scheduled in-office follow-ups * 48-hour Holter ECG

all patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (27)

GenesisCare Wesley

Auchenflower, Australia

Location

GenesisCare Bundaberg

Bundaberg, Australia

Location

GenesisCare Doncaster

Doncaster East, Australia

Location

Canberra Heart Rhythm Clinic

Garran, Australia

Location

Prince of Wales Hospital

Randwick, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

Kepler Universitätsklinikum

Linz, Austria

Location

Allgemeines Krankenhaus der Stadt Wien (AKH)

Vienna, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Austria

Location

Regionshospitalet Viborg

Viborg, Denmark

Location

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, Germany

Location

Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH (UKGM)

Giessen, Germany

Location

Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, Germany

Location

Klinikum St. Georg gGmbH

Leipzig, Germany

Location

Klinikum Leverkusen Service GmbH

Leverkusen, Germany

Location

St.-Marien-Hospital GmbH

Lünen, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Hospital del Bierzo

León, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

CHUV - Centre Hospitalier Universitaire Vaudoise

Lausanne, Switzerland

Location

Fondazione Cardiocentro Ticino

Lugano, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Tachycardia; Atrial Fibrillation; Syncope; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases

Results Point of Contact

• Title: Senior Director Clinical Project Management
• Organization: BIOTRONIK SE & Co.KG

mathias.freudigmann@biotronik.com

+49 30 68905

Study Officials

• Thomas Deneke, Prof. Dr.

  RHÖN-KLINIKUM Campus Bad Neustadt, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: October 17, 2019
• Primary Completion: June 30, 2021
• Study Completion: April 6, 2022
• Last Updated: November 27, 2024
• Results First Posted: January 11, 2024

Record last verified: 2022-11

Locations

AU (6); ES (3); DK (1); CH (3); DE (11)