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Essai clinique

Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility

NCT : NCT05821465 · COMPLETED

ID NCTNCT05821465
StatutCOMPLETED
Date de début2023-07-01
Achèvement2024-07-18
SponsorHelpWear Inc. (INDUSTRY)
First posted
Last updated

Résumé succinct

The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question\[s\] it aims to answer are: 1. Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices? 2. Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.

Source officielle

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