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出境医 / 临床实验 / Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

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

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.

Condition or disease Intervention/treatment Phase
Tachyarrhythmia Atrial Fibrillation (AF) Syncope Cryptogenic Stroke Device: BIOMONITOR III and BIOMONITOR IIIm Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: BIO|MASTER.BIOMONITOR III
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022
Arms and Interventions
Arm Intervention/treatment
all patients Device: BIOMONITOR III and BIOMONITOR IIIm
  • Insertion of BIOMONITOR III or BIOMONITOR IIIm
  • three scheduled in-office follow-ups
  • 48-hour Holter ECG
Outcome Measures
Primary Outcome Measures :
  1. SADE-free rate until the 3-month follow-up [ Time Frame: 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 :
  1. R-wave amplitude [ Time Frame: 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.

  2. Noise burden [ Time Frame: 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.

  3. Assessment of P-wave visibility [ Time Frame: 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.

  4. SADE-free rate until the 12-month follow-up [ Time Frame: 12-months ]
    The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Show Show 27 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Layout table for investigator information
Principal Investigator: Thomas Deneke, Prof. Dr. RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE October 17, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020) 		SADE-free rate until the 3-month follow-up [ Time Frame: 3 months ]
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		SADE-free rate until the 3-month follow-up [ Time Frame: 3 months ]
SADE-free rate related to BIOMONITOR III including incision and insertion tool set until 3-month follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • R-wave amplitude [ Time Frame: 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.
  • Noise burden [ Time Frame: 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.
  • Assessment of P-wave visibility [ Time Frame: 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.
  • SADE-free rate until the 12-month follow-up [ Time Frame: 12-months ]
    The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • R-wave amplitude [ Time Frame: 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.
  • Noise burden [ Time Frame: 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.
  • Assessment of P-wave visibility [ Time Frame: 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.
  • SADE-free rate until the 12-month follow-up [ Time Frame: 12-months ]
    The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III 12 months after insertion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Official Title  ICMJE BIO|MASTER.BIOMONITOR III
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Tachyarrhythmia
  • Atrial Fibrillation (AF)
  • Syncope
  • Cryptogenic Stroke
Intervention  ICMJE Device: BIOMONITOR III and BIOMONITOR IIIm
  • Insertion of BIOMONITOR III or BIOMONITOR IIIm
  • three scheduled in-office follow-ups
  • 48-hour Holter ECG
Study Arms  ICMJE all patients
Intervention: Device: BIOMONITOR III and BIOMONITOR IIIm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 17, 2021) 		167
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		157
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Denmark,   Germany,   Spain,   Switzerland
Removed Location Countries New Zealand
 
Administrative Information
NCT Number  ICMJE NCT04025710
Other Study ID Numbers  ICMJE BA109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor  ICMJE Biotronik SE & Co. KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Deneke, Prof. Dr. RHÖN-KLINIKUM Campus Bad Neustadt, Germany
PRS Account Biotronik SE & Co. KG
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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