Back to resultsMaster Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Primary Purpose
Tachyarrhythmia, Atrial Fibrillation (AF), Syncope
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BIOMONITOR III and BIOMONITOR IIIm
Sponsored by
About this trial
This is an interventional other trial for Tachyarrhythmia
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.
Sites / Locations
- GenesisCare Wesley
- GenesisCare Bundaberg
- GenesisCare Doncaster
- Canberra Heart Rhythm Clinic
- Prince of Wales Hospital
- Princess Alexandra Hospital
- Kepler Universitätsklinikum
- Klinikum Wels-Grieskirchen
- Allgemeines Krankenhaus der Stadt Wien (AKH)
- Regionshospitalet Viborg
- RHÖN-KLINIKUM Campus Bad Neustadt
- Herz- und Diabeteszentrum NRW
- Städtisches Klinikum Dresden-Friedrichstadt
- Universitätsklinik an der Technischen Universität Dresden
- SRH Wald-Klinikum Gera GmbH
- Universitätsklinikum Gießen und Marburg GmbH (UKGM)
- Ernst-Moritz-Arndt-Universität Greifswald
- Klinikum St. Georg gGmbH
- Klinikum Leverkusen Service GmbH
- St.-Marien-Hospital GmbH
- Johannes Wesling Klinikum Minden
- Hospital del Bierzo
- Complejo Hospitalario de Ourense
- Hospital Universitario Marques de Valdecilla
- CHUV - Centre Hospitalier Universitaire Vaudoise
- Fondazione Cardiocentro Ticino
- Kantonsspital St. Gallen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
all patients
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04025710
Brief Title
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Official Title
BIO|MASTER.BIOMONITOR III
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
April 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all patients
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
BIOMONITOR III and BIOMONITOR IIIm
Intervention Description
Insertion of BIOMONITOR III or BIOMONITOR IIIm
three scheduled in-office follow-ups
48-hour Holter ECG
Primary Outcome Measure Information:
Title
SADE-free rate until the 3-month follow-up
Description
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
R-wave amplitude
Description
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.
Time Frame
10 days to 4 weeks after insertion; 3-months
Title
Noise burden
Description
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.
Time Frame
10 days to 4 weeks after insertion; 3-months
Title
Assessment of P-wave visibility
Description
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.
Time Frame
10 days to 4 weeks after insertion; 3-months
Title
SADE-free rate until the 12-month follow-up
Description
The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Time Frame
12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, Prof. Dr.
Organizational Affiliation
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
GenesisCare Wesley
City
Auchenflower
Country
Australia
Facility Name
GenesisCare Bundaberg
City
Bundaberg
Country
Australia
Facility Name
GenesisCare Doncaster
City
Doncaster East
Country
Australia
Facility Name
Canberra Heart Rhythm Clinic
City
Garran
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien (AKH)
City
Wien
Country
Austria
Facility Name
Regionshospitalet Viborg
City
Viborg
Country
Denmark
Facility Name
RHÖN-KLINIKUM Campus Bad Neustadt
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Facility Name
Städtisches Klinikum Dresden-Friedrichstadt
City
Dresden
Country
Germany
Facility Name
Universitätsklinik an der Technischen Universität Dresden
City
Dresden
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH (UKGM)
City
Giessen
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
Country
Germany
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
Country
Germany
Facility Name
Klinikum Leverkusen Service GmbH
City
Leverkusen
Country
Germany
Facility Name
St.-Marien-Hospital GmbH
City
Lünen
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Facility Name
Hospital del Bierzo
City
León
Country
Spain
Facility Name
Complejo Hospitalario de Ourense
City
Ourense
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
Country
Spain
Facility Name
CHUV - Centre Hospitalier Universitaire Vaudoise
City
Lausanne
Country
Switzerland
Facility Name
Fondazione Cardiocentro Ticino
City
Lugano
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
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