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

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Wearing Cardioskin™ for 14 days
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Holter Monitor, ECG Monitor, Cardioskin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht Universitair Medisch Centrum
  • Universitair Medisch Centrum Groningen
  • Martini Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardioskin™ and 3-lead Holter recorder

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
The incidence of device related (serious) adverse events [safety].
The incidence of device related (serious) adverse events during the course of the clinical investigation.

Secondary Outcome Measures

Time until first "definite" AF (≥ 30 seconds) episode detection of the Cardioskin™.
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)
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.
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.
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).
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.

Full Information

First Posted
May 23, 2019
Last Updated
May 4, 2021
Sponsor
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT03964025
Brief Title
Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Official Title
Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
project stopped by the sponsor
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Holter Monitor, ECG Monitor, Cardioskin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardioskin™ and 3-lead Holter recorder
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Wearing Cardioskin™ for 14 days
Intervention Description
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.
Primary Outcome Measure Information:
Title
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].
Description
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
Title
The incidence of device related (serious) adverse events [safety].
Description
The incidence of device related (serious) adverse events during the course of the clinical investigation.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time until first "definite" AF (≥ 30 seconds) episode detection of the Cardioskin™.
Description
Time until first "definite" AF episode detected by the Cardioskin™.
Time Frame
14 days
Title
Incidence and length of AF episodes after 13 day recording period with Cardioskin™ (based on standard ECG analysis)
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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