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

Not Applicable

Completed

• Conditions: Syncope; Cryptogenic Stroke; Tachyarrhythmia; Atrial Fibrillation (AF)
• Interventions: Device: BIOMONITOR III and BIOMONITOR IIIm

• Registration Number: NCT04025710
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-10-17
• Primary Completion: 2021-06-30
• Study Completion: 2022-04-06
• Status Verified: 2022-11
• Results First Submitted: 2023-04-03
• Results First Submitted QC: 2023-04-03
• Results First Posted: 2024-01-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients	BIOMONITOR III and BIOMONITOR IIIm	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Noise Burden	10 days to 4 weeks after insertion; 3-months	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.
R-wave Amplitude	10 days to 4 weeks after insertion; 3-months	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.
SADE-free Rate Until the 12-month Follow-up	12-months	The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Assessment of P-wave Visibility	10 days to 4 weeks after insertion; 3-months	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.

Trial Locations

Locations (27)

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Klinikum Wels-Grieskirchen; 🇦🇹 Wels, Austria

Hospital del Bierzo; 🇪🇸 León, Spain

Complejo Hospitalario de Ourense; 🇪🇸 Ourense, Spain

GenesisCare Wesley; 🇦🇺 Auchenflower, Australia

GenesisCare Bundaberg; 🇦🇺 Bundaberg, Australia

Canberra Heart Rhythm Clinic; 🇦🇺 Garran, Australia

GenesisCare Doncaster; 🇦🇺 Doncaster East, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, Australia

Allgemeines Krankenhaus der Stadt Wien (AKH); 🇦🇹 Wien, Austria

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 Leverkusen Service GmbH; 🇩🇪 Leverkusen, Germany

St.-Marien-Hospital GmbH; 🇩🇪 Lünen, Germany

Klinikum St. Georg gGmbH; 🇩🇪 Leipzig, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

CHUV - Centre Hospitalier Universitaire Vaudoise; 🇨🇭 Lausanne, Switzerland

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Fondazione Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark