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

NCT ID: NCT04025710

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2022-04-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

all patients

Group Type: OTHER

BIOMONITOR III and BIOMONITOR IIIm

Intervention Type: DEVICE

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

Interventions

BIOMONITOR III and BIOMONITOR IIIm

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Deneke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Locations

GenesisCare Wesley

Auchenflower, , Australia

GenesisCare Bundaberg

Bundaberg, , Australia

GenesisCare Doncaster

Doncaster East, , Australia

Canberra Heart Rhythm Clinic

Garran, , Australia

Prince of Wales Hospital

Randwick, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Kepler Universitätsklinikum

Linz, , Austria

Allgemeines Krankenhaus der Stadt Wien (AKH)

Vienna, , Austria

Klinikum Wels-Grieskirchen

Wels, , Austria

Regionshospitalet Viborg

Viborg, , Denmark

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, , Germany

Universitätsklinik an der Technischen Universität Dresden

Dresden, , Germany

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Universitätsklinikum Gießen und Marburg GmbH (UKGM)

Giessen, , Germany

Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, , Germany

Klinikum St. Georg gGmbH

Leipzig, , Germany

Klinikum Leverkusen Service GmbH

Leverkusen, , Germany

St.-Marien-Hospital GmbH

Lünen, , Germany

Johannes Wesling Klinikum Minden

Minden, , Germany

Hospital del Bierzo

León, , Spain

Complejo Hospitalario de Ourense

Ourense, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

CHUV - Centre Hospitalier Universitaire Vaudoise

Lausanne, , Switzerland

Fondazione Cardiocentro Ticino

Lugano, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Countries

Australia; Austria; Denmark; Germany; Spain; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BA109

Identifier Type: -

Identifier Source: org_study_id