This is a prospective, non-randomized, comparative, single-arm, open label, multi- centre, post-market clinical investigation involving an expected 74 subjects (minimum 40, maximum 118) suffering from paroxysmal AF with the aim to determine the accuracy of "definitive" AF detection (≥30 seconds) of the Cardioskin™ as compared to a 3-lead Holter recorder in patients with known paroxysmal AF.
This is a prospective, non-randomized, comparative, single-arm, open label, multi-centre, post-marketing clinical investigation involving an expected 74 subjects (minimum 40, maximum 118) suffering from paroxysmal AF. The clinical investigation will include a screening visit to determine subject eligibility, an inclusion visit where (additional) baseline characteristics will be collected and the subject will receive the investigational device (Cardioskin™) and comparator device (3-lead Holter recorder) (Visit 1), and 2 additional study visits. The subject will be wearing both the Cardioskin™ and 3-lead Holter recorder for a period of 24 hours, after which the subject will continue wearing the Cardioskin™ alone for an additional period of 13 days. The clinical investigation primarily aims to determine the accuracy of AF detection (≥30 seconds) of the Cardioskin™ wearable 15 lead ECG monitor as compared to a 3 lead Holter recorder in patients with known paroxysmal AF. Further objectives of the clinical investigation include detection of AF for the 13 additional days, detection of other arrhythmias and patient safety. A 3 lead Holter recorder was selected as the comparator device, because it is currently the gold standard for 24-hour home-based ECG monitoring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
The current standard of care for diagnosing AF is through the use of a 24 hour Holter device. In this study, in addition to wearing the 3-lead Holter recorder for 24 hours, the subject will be wearing the Cardioskin™ for a period of 24 hours as well, after which the subject will continue wearing the Cardioskin™ alone for an additional period of 13 days.
Maastricht Universitair Medisch Centrum
Maastricht, Limburg, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Sensitivity, specificity, positive and negative likelihood ratio, positive and negative predicted value of recording "definite" AF episodes (≥30 seconds) with the Cardioskin™ versus 3-lead Holter recorder after a 24 hour recording period[performance].
Sensitivity, specificity, positive and negative likelihood ratio, and positive and negative predicted value of recording "definite" AF episodes (≥30 seconds) with the Cardioskin™ versus the 3-lead Holter recorder after a 24 hour recording period (adjudicated events)
Time frame: 24 hours
The incidence of device related (serious) adverse events [safety].
The incidence of device related (serious) adverse events during the course of the clinical investigation.
Time frame: 14 days
Time until first "definite" AF (≥ 30 seconds) episode detection of the Cardioskin™.
Time until first "definite" AF episode detected by the Cardioskin™.
Time frame: 14 days
Incidence and length of AF episodes after 13 day recording period with Cardioskin™ (based on standard ECG analysis)
The incidence and length of AF episodes after a 13 day recording period, based on a standard ECG analysis, after first "definite" AF episode detected during this period.
Time frame: 13 days
Qualitative comparison of the relevant cardiac parameters as recorded by the Cardioskin™ to these recorded by a 3-lead holter, as assessed per standard ECG analysis after 24 hours.
A qualitative comparison of the relevant cardiac parameters as recorded by the Cardioskin™ to these recorded by a 3-lead Holter recorder, assessed per standard ECG analysis.
Time frame: 24 hours
The timing and frequency of subject reported AF episodes and timing, frequency and duration of AF episodes as detected by Cardioskin™ after 14 day recording period.
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The timing and frequency of AF symptoms as recorded by the subject and the timing, frequency and duration of AF episodes as detected by the Cardioskin™ after a 14 day recording period.
Time frame: 14 days
Frequency and duration (total duration & longest) of arrhythmia symptoms as recorded by the subject and the nature, timing, frequency and duration (longest) of arrhythmia as detected by Cardioskin™ after a 14 day period(based on standard ECG analysis).
The timing and frequency of arrhythmia symptoms as recorded by the subject and the nature, timing, frequency and duration of arrhythmias as detected by the Cardioskin™ after a 14 day recording period, based on a standard ECG analysis.
Time frame: 14 days