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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025710
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 157 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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025710


Contacts
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Contact: Anja Viehrig, Dr. +49 (0) 30 68905-1304 anja.viehrig@biotronik.com
Contact: Gabriel Knop-Sedmak +49 (0) 30 68905-1208 gabriel.knop@biotronik.com

Locations
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Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Thomas Deneke, Prof. Dr. RHÖN-KLINIKUM Campus Bad Neustadt, Germany
More Information
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT04025710    
Other Study ID Numbers: BA109
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syncope
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Cardiac Conduction System Disease