Clinical trial NCT05357716: Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
Official title: Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Tachycardia, Supraventricular
Bradyarrhythmia
Ventricular Arrythmia
Lead sponsor: HelpWear Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 7
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to participating clinics for extended ambulatory ECG testing. Subjects referred for extended ambulatory ECG testing will be recruited from the Toronto Heart Centre. Referring physicians will be asked to indicate if longer-term (i.e., Event Recorder) or shorter-term monitoring (i.e., Holter monitor) is desired for a given patient.

Brief summary: The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.


Eligibility criteria: Inclusion Criteria:

* At least 22 years of age at time of consent
* Clinically-indicated for an ambulatory Event Recorder or Holter monitor
* Able to follow the protocol
* Provision of written-informed consent

Exclusion Criteria:

* Known allergy to any component of the Event Recorder
* Known allergy to any component of the Holter monitor
* Known allergy to any component of the HeartWatch
* Dextrocardia

Primary outcomes:
measure: Pairing HeartWatch and Event Recorder
timeFrame: Up to 6 months, with 3 months of analysis time (9 months total)
measure: Pairing HeartWatch and Holter
timeFrame: Up to 6 months, with 3 months of analysis time (9 months total)
Secondary outcomes:
measure: Body Position and Activity
timeFrame: Up to 6 months, with 3 months of analysis time (9 months total)
Other outcomes:
measure: Adverse Events
timeFrame: Up to 6 months, with 3 months of analysis time (9 months total)
measure: User Preferences
timeFrame: Up to 6 months, with 3 months of analysis time (9 months total)
Locations:
city: Toronto
country: Canada
facility: HelpWear Inc
state: Ontario
Study officials:
References: