Clinical trial NCT04025710: Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Official title: BIO|MASTER.BIOMONITOR III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachyarrhythmia
Atrial Fibrillation (AF)
Syncope
Cryptogenic Stroke
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: SADE-free Rate Until the 3-month Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: R-wave Amplitude
timeFrame: 10 days to 4 weeks after insertion; 3-months
measure: Noise Burden
timeFrame: 10 days to 4 weeks after insertion; 3-months
measure: Assessment of P-wave Visibility
timeFrame: 10 days to 4 weeks after insertion; 3-months
measure: SADE-free Rate Until the 12-month Follow-up
timeFrame: 12-months
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: GenesisCare Wesley
city: Bundaberg
country: Australia
facility: GenesisCare Bundaberg
city: Doncaster East
country: Australia
facility: GenesisCare Doncaster
city: Garran
country: Australia
facility: Canberra Heart Rhythm Clinic
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH)
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
city: Bad Neustadt An Der Saale
country: Germany
facility: RHÖN-KLINIKUM Campus Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Universitätsklinik an der Technischen Universität Dresden
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH (UKGM)
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen Service GmbH
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: León
country: Spain
facility: Hospital del Bierzo
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Lausanne
country: Switzerland
facility: CHUV - Centre Hospitalier Universitaire Vaudoise
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: RHÖN-KLINIKUM Campus Bad Neustadt, Germany
name: Thomas Deneke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: