Continuous vital sign Monitoring with a Mobile Device in patients with high risk for Atrial fibrillation to identify and evaluate algorithms that detect A-fib episodes - CoMMoD-A-fib

niversität Witten/Herdecke0 个研究点目标入组 100 人开始时间: 2018年6月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Age =18 years and able to understand design and objectives of the trial
•Patients with indication for ECG Holter monitoring, because of high risk for A-fib episodes (including at least 10 patients identified retrospectively to have a sinus rhythm)
•Willingness to continuously wear the additional device throughout the evaluation period
•Written informed consent and data safety agreement will be obtained before any trial-related activities

•Medical or mental conditions (e.g. dementia) impairing the ability to continuously wear the device throughout the evaluation period
•Wearing any active implants (e.g. pacemaker)
•Tattoos on the upper arm
•Presence of skin disease on the upper arm
•Allergic reaction to the device or its components (e.g. synthetic fabrics)
•Relevant coagulation disorder (e.g. known platelet count <30.000/µl)
•History of non-functional hemoglobin (Sickle-cell anemia, recent carbon monoxide intoxication)
•Mental incapacity or language barriers which preclude adequate understanding or cooperation, known or suspected not to comply with trial directives or not to be reliable or trustworthy, or subject who in the opinion of the investigator should not participate in the trial

发起方

niversität Witten/Herdecke