TachyarrhythmiaNCT04025710
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
A study testing BIOMONITOR III and BIOMONITOR IIIm in people with Tachyarrhythmia and Atrial Fibrillation (AF), run by Biotronik SE & Co. KG at 27 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope
- What is being tested?
- BIOMONITOR III and BIOMONITOR IIIm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 17 Oct 2019to 6 Apr 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Germany11 sites
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Städtisches Klinikum Dresden-Friedrichstadt
Dresden
Universitätsklinik an der Technischen Universität Dresden
Dresden
SRH Wald-Klinikum Gera GmbH
Gera
Universitätsklinikum Gießen und Marburg GmbH (UKGM)
Giessen
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald
Klinikum St. Georg gGmbH
Leipzig
Klinikum Leverkusen Service GmbH
Leverkusen
St.-Marien-Hospital GmbH
Lünen
Johannes Wesling Klinikum Minden
Minden
Australia6 sites
GenesisCare Wesley
Auchenflower
GenesisCare Bundaberg
Bundaberg
GenesisCare Doncaster
Doncaster East
Canberra Heart Rhythm Clinic
Garran
Prince of Wales Hospital
Randwick
Princess Alexandra Hospital
Woolloongabba
Austria3 sites
Kepler Universitätsklinikum
Linz
Allgemeines Krankenhaus der Stadt Wien (AKH)
Vienna
Klinikum Wels-Grieskirchen
Wels
Spain3 sites
Hospital del Bierzo
León
Complejo Hospitalario de Ourense
Ourense
Hospital Universitario Marques de Valdecilla
Santander
Switzerland3 sites
CHUV - Centre Hospitalier Universitaire Vaudoise
Lausanne
Fondazione Cardiocentro Ticino
Lugano
Kantonsspital St. Gallen
Sankt Gallen
About this study
Official title: BIO|MASTER.BIOMONITOR III
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
- Being tested
- BIOMONITOR III and BIOMONITOR IIIm
- Medical subject headings
- Tachycardia, Atrial Fibrillation, Syncope, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOMONITOR III and BIOMONITOR IIImDevice
- Insertion of BIOMONITOR III or BIOMONITOR IIIm
- three scheduled in-office follow-ups
- 48-hour Holter ECG
| Study group | Role | What they receive |
|---|---|---|
| all patients | Other | Not described Receives: Device: BIOMONITOR III and BIOMONITOR IIIm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 10 days to 4 weeks after insertion; 3-months
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.
Measured: 10 days to 4 weeks after insertion; 3-months
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.
Measured: 10 days to 4 weeks after insertion; 3-months
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start17 Oct 2019
- Primary completion30 Jun 2021
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Deneke, Prof. Dr., Principal investigator, RHÖN-KLINIKUM Campus Bad Neustadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025710
- Sponsor's protocol ID
- BA109
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2019
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No