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Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03964025
Recruitment Status : Not yet recruiting
First Posted : May 27, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 27, 2019
Last Update Posted Date June 26, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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]. [ Time Frame: 24 hours ]
    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)
  • The incidence of device related (serious) adverse events [safety]. [ Time Frame: 14 days ]
    The incidence of device related (serious) adverse events during the course of the clinical investigation.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Determining 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. [ Time Frame: 24 hours ]
    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)
  • The safety of Cardioskin™. [ Time Frame: 14 days ]
    The incidence of device related (serious) adverse events during the course of the clinical investigation.
Change History Complete list of historical versions of study NCT03964025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Time until first "definite" AF (≥ 30 seconds) episode detection of the Cardioskin™. [ Time Frame: 14 days ]
    Time until first "definite" AF episode detected by the Cardioskin™.
  • Incidence and length of AF episodes after 13 day recording period with Cardioskin™ (based on standard ECG analysis) [ Time Frame: 13 days ]
    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.
  • 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. [ Time Frame: 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.
  • 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. [ Time Frame: 14 days ]
    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.
  • 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). [ Time Frame: 14 days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • To examine the time until first AF episode detection of the Cardioskin™. [ Time Frame: 14 days ]
    Time until first "definite" AF episode detected by the Cardioskin™.
  • To determine the ability of Cardioskin™ to detect AF in patients with known paroxysmal AF. [ Time Frame: 13 days ]
    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.
  • To investigate the quality of the signals of Cardioskin™ as compared to a 3-lead Holter recorder. [ Time Frame: 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.
  • To investigate the relation between AF episode symptoms (actively recorded by the patient) and AF episodes detected by Cardioskin™. [ Time Frame: 14 days ]
    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.
  • To examine other arrhythmias as detected with the Cardioskin™ and the relation between arrhythmia symptoms (actively recorded by the patient) and arrhythmias detected by Cardioskin™. [ Time Frame: 14 days ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Official Title  ICMJE Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: Wearing Cardioskin™ for 14 days
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.
Study Arms  ICMJE Experimental: Cardioskin™ and 3-lead Holter recorder
This is single-arm study. All subjects will receive the investigational device (Cardioskin™) and comparator device (3-lead Holter recorder).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.
Intervention: Device: Wearing Cardioskin™ for 14 days
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The subject shall only be enrolled in the clinical investigation if he/she:

  • is willing and able to understand and sign informed consent, and has signed an information and inform consent;
  • is male or female;
  • has a documented history of AF in the 3 months prior to screening e.g. by means of an ECG report, with at least one episode ≥30 seconds;
  • has a subject reported frequency of at least one AF episode in the 48 hours prior to screening, as defined by AF related complaints;
  • is on stable cardiovascular medication in the 2 weeks prior to screening and no changes to the cardiovascular medication are expected for the duration of the clinical investigation;
  • has body weight characteristics that are compatible with the proposed models of Cardioskin™ (the subject fits the t-shirt);
  • is minimum 18 years of age when signing informed consent;
  • is willing and able to comply with the instructions outlined in the User Manual of the investigational device;
  • is willing and able to comply with the instructions outlined in the User Manual of the Holter recorder (;
  • is willing and able to comply to the schedule of assessment of the clinical investigation.

Exclusion Criteria:

The subject shall not be enrolled in the clinical investigation if he/she:

  • has an implantable loop recorder; NOTE: this exclusion criterion is not applicable to all subjects in the clinical investigation. This exclusion criterion comes into effect once 4 subjects have been enrolled with an implantable loop recorder. This number of 4 may increase, to a maximum of 10% of enrolled subjects.
  • has an implanted pacemaker or defibrillator;
  • is lactating, pregnant, or planning to become pregnant during the course of the clinical investigation;
  • is an alcohol and/or drugs abuser, on the investigator judgement and based on the patient questioning;
  • has a known allergy to one of the components of the Cardioskin™ garment, including:

    • polyamide;
    • polyester;
    • elastane;
    • silicone;
    • silver;
    • any synthetic material.
  • has a known allergy to ECG stickers;
  • has a lot of chest hair;
  • has a sensory disorder making the patient insensitive to pain on the skin;
  • has behavioural problems making the patient excessively agitated or aggressive;
  • has motor or mental disorders preventing the patient from expressing pain;
  • has cardiorespiratory disorders which may be aggravated by the slight compression of the thorax;
  • has an open wound on the skin, in the area either covered or surrounded by Cardioskin™ textile;
  • has a strong contagious risk to any material composing Cardioskin™;
  • is currently participating in, or has recently exited from (within 30 days prior to screening for this clinical investigation), or plans to be enrolled (during the course of this clinical investigation) in another clinical investigation.

In addition, subjects shall be excluded on sex (male/female) if an enrolment of 60% for one of the genders has been reached. At the end of the study, maximum 60% of the enrolled subjects shall be male and maximum 60% of the subjects shall be female.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claire Tailliandier +33155724079 claire.tailliandier@servier.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964025
Other Study ID Numbers  ICMJE CL3-13001-002
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
Plan to Share IPD: No
Responsible Party Servier ( Institut de Recherches Internationales Servier )
Study Sponsor  ICMJE Institut de Recherches Internationales Servier
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Servier
Verification Date May 2019

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