Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- 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].
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
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].
时间窗: 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].
时间窗: 14 days
The incidence of device related (serious) adverse events during the course of the clinical investigation.
次要结局
- 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)