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

NCT03964025 | Withdrawn

• 1 other identifier: CL3-13001-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

Holter Monitor; ECG Monitor; Cardioskin

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  14 days

Secondary Outcomes (5)

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

  14 days

• Incidence and length of AF episodes after 13 day recording period with Cardioskin™ (based on standard ECG analysis)

  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.

  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.

  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).

  14 days

Study Arms (1)

Cardioskin™ and 3-lead Holter recorder

EXPERIMENTAL

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.

Device: Wearing Cardioskin™ for 14 days

Interventions

Wearing Cardioskin™ for 14 days DEVICE

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.

Cardioskin™ and 3-lead Holter recorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead

Study Sites (3)

Maastricht Universitair Medisch Centrum

Maastricht, Limburg, 6229 HX, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: July 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)