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Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Code de protocole Servier:
CL3-13001-002
Sponsor:
Institut de Recherches Internationales Servier
Identifiant Clinicaltrials.gov:
NCT03964025
Trouver un site de recrutement
Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Nom:
Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone:
+33 1 55 72 60 00
L'étude a 3 centres
Description de l'étude
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.
Titre officiel: Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
Indications
Atrial Fibrillation
Interventions / Traitements
Le ou les traitements administrés aux participants à l'étude.
- Wearing Cardioskin™ for 14 days
Autres numéros d'identification
Autres numéros d'identification sous lesquels l'étude peut être connue.
- CL3-13001-002
Critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Age éligible pour l’étude
18 ans et plus
(Adulte, Adulte plus âgé)
Sexe
Homme/FemmeAccepte les volontaires en bonne santé
Non- 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.
- 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.
Comment l'étude est-elle conçue ?
Allocation
Comment les participants sont répartis dans différents groupes. La répartition peut être aléatoire (randomisée) ou prédéterminée (non randomisée). Randomisée signifie que les participants sont répartis de manière aléatoire dans leur groupe/branche.
Modèle d'étude interventionnelle
Comment les traitements sont administrés et testés dans le cadre d'une étude.
Groupe unique
Une étude à groupe unique consiste à étudier un groupe de participants qui reçoivent tous le même traitement. Les chercheurs observent les résultats du groupe afin de comprendre les effets du traitement.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Expérimental:
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 / Traitement
Le ou les traitements administrés aux participants à l'étude.
Dispositif:
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.
Mots clés
Fournis par Servier
Holter Monitor
ECG Monitor
Cardioskin
Autres termes
Atrial Fibrillation