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

Syncope Clinical Trial

Official title:

BIO|MASTER.BIOMONITOR III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025710
• Other study ID #: BA109
• Status: Completed
• Phase: N/A
• Start date: October 17, 2019
• Est. completion date: April 6, 2022

Study information

• Verified date: November 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: April 6, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)
• Cryptogenic Stroke
• Ischemic Stroke
• Syncope
• Tachyarrhythmia
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
Australia	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
Austria	Kepler Universitätsklinikum	Linz
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Allgemeines Krankenhaus der Stadt Wien (AKH)	Wien
Denmark	Regionshospitalet Viborg	Viborg
Germany	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
Spain	Hospital del Bierzo	León
Spain	Complejo Hospitalario de Ourense	Ourense
Spain	Hospital Universitario Marques de Valdecilla	Santander
Switzerland	CHUV - Centre Hospitalier Universitaire Vaudoise	Lausanne
Switzerland	Fondazione Cardiocentro Ticino	Lugano
Switzerland	Kantonsspital St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  Austria,  Denmark,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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