Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs. In this trial, patients with implanted ICMs (Medtronic Reveal LINQ Insertable Cardiac Monitor) will be randomized to use one of two wearables (1:1 Apple Watch or PulseOn) for continuous monitoring. The aim is to compare the probability of detecting an episode of AF with a wearable versus the gold standard ICM. Both groups will use the wearable for 12 weeks. If the wearables detect an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed. ECG data will be transferred regularly to the CoreLab (Universityhospital Leipzig) for analysis. After 12 weeks, the patients will visit the site and answer questions regarding the usability, compliance and satisfaction with the wearables.
Patients with established continuous ICM monitoring from the prospective, randomized, multicenter study Find-AF 2 (NCT04371055) are recruited for this trial. Find-AF 2 is being carried out at Leipzig University Hospital since 2020 with the help of about 50 study centers throughout Germany. The AppleWatch Series 10, a device from the current market leader, was chosen because extensive data from clinical trials is already available and data regarding the market leader has particular societal relevance. The AF detection algorithm is based on photoplethysmography (analysis of the pulse current curve) and semicontinuous monitoring. If a rhythm irregularity is detected during hourly measurements, the measurement interval is shortened. If this finding is confirmed in several consecutive measurements, the user is notified. In this pilot study, patients are trained to record a 30-second ECG with the AppleWatch in the event of notification. This is done by placing the other hand on the crown of the watch. The report will then be transmitted. The AppleWatch must be paired with another Apple device (e.g. iPhone) to use the ECG app and must be charged daily (battery life 18 hours). Our patients are provided with an iPhone for study use and are trained in using the AppleWatch. The AppleWatch is not certified as medical device, but the ECG data collected by the AppleWatch will be used for research purposes only and not for therapeutical or diagnostical purposes. The second wearable will be the PulseOn device. The battery lasts over two weeks. No additional device is needed for writing an ECG. AF screening is also performed photoplethysmographically. In the case of detection of an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed for registration. Regular data transfer is done at the patient's home via a gateway device to the PulseOn server. The Core lab will monitor the data transmission. Although PulseOn is a certified medical device, the ECG data collected by the PulseOn device will be used for research purposes only and not for therapeutical or diagnostical purposes. The ICM is the gold standard for recording relevant arrhythmias.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
semi-continuous heart rhythm monitoring with Wearable
RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung
Bad Neustadt an der Saale, Germany
NOT_YET_RECRUITINGEvangelisches Klinikum Bethel, Clinic for Neurology
Bielefeld, Germany
RECRUITINGMedizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, Germany
NOT_YET_RECRUITINGUniversity of Essen, Clinic of Neurology
Essen, Germany
RECRUITINGUniversity of Göttingen, Clinic for Neurology
Göttingen, Germany
RECRUITINGBezirkskrankenhaus Günzburg Klinik für Neurologie und Neurologische Rehabilitation Ludwig-Heilmeyer-Straße 2
Günzburg, Germany
NOT_YET_RECRUITINGKrankenhaus Martha-Maria Halle-Dölau
Halle, Germany
RECRUITINGKlinik für Neurologie Klinikum Ibbenbüren Große Str. 41
Ibbenbueren, Germany
NOT_YET_RECRUITINGUniversity Hospital Leipzig, Clinic for Neurology
Leipzig, Germany
RECRUITINGUniversity of Mainz, Clinic for Neurology
Mainz, Germany
RECRUITING...and 3 more locations
sensitivity as a function of AF duration
the probability that an AF episode will be detected as it depends on the duration of the episode
Time frame: from the date of device handover to the date of device return
Time worn
the proportion of time that the wearable collected and transferred data
Time frame: from the date of device handover to the date of device return
Detection sensitivity as a function of AF duration
If the device is being worn during at least 120 seconds of an AF episode, what is the probability of its informing the patient of an arrhythmia?
Time frame: from the date of device handover to the date of device return
ECG compliance
if the wearable informs of an episode, what is the probability that the patient will let the device save an ECG
Time frame: from the date of device handover to the date of device return
Overall sensitivity
For patients who had at least one AF episode, what is the probability that the wearable claims there was at least one episode?
Time frame: from the date of device handover to the date of device return
Time to first ECG-confirmed AF episode
Time frame: from the date of device handover to the date of device return
Overall specificity
for patients who had no AF episodes, what is the probability that there is no ECG confirmation of any episodes?
Time frame: from the date of device handover to the date of device return
False discovery rate (1-PPV (positive predictive value)
For every ECG-confirmed episode found by the wearable, the gold standard episode definition will be used for comparison
Time frame: from the date of device handover to the date of device return
For the ICM: What proportion of detected signals are available as ECGs?
Time frame: from the date of device handover to the date of device return
For the ICM: What is the false discovery rate of the available ECGs?
Time frame: from the date of device handover to the date of device return
Do patients with an ICM claim to be willing to be randomized to an ICM vs a wearable?
Time frame: after 12 weeks
Patient satisfaction with the wearable
Time frame: after 12 weeks
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