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

Study Overview
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Brief Summary
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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.

Official Title
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BIO|MASTER.BIOMONITOR III

Conditions
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Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke

Intervention / Treatment
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* Device: BIOMONITOR III and BIOMONITOR IIIm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: all patients<br> | Device: BIOMONITOR III and BIOMONITOR IIIm<br>* Insertion of BIOMONITOR III or BIOMONITOR IIIm three scheduled in-office follow-ups 48-hour Holter ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 12-months |