Atrial Fibrillation Clinical Trial
— PRE-ALERTOfficial title:
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
NCT number | NCT05357716 |
Other study ID # | 1.1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2020 |
Est. completion date | October 2, 2023 |
Verified date | April 2022 |
Source | HelpWear Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | October 2, 2023 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | HelpWear Inc | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
HelpWear Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Incidence of adverse events among the HeartWatch and comparator devices and the types of adverse events | Up to 6 months, with 3 months of analysis time (9 months total) | |
Other | User Preferences | User preferences of subjects with the HeartWatch versus the comparator devices | Up to 6 months, with 3 months of analysis time (9 months total) | |
Primary | Pairing HeartWatch and Event Recorder | Can paired user-triggered (tagged) and auto-triggered ECG data from the HeartWatch and Event Recorder be successfully collected? | Up to 6 months, with 3 months of analysis time (9 months total) | |
Primary | Pairing HeartWatch and Holter | Can paired continuous ECG data from the HeartWatch and Holter monitor be successfully collected? | Up to 6 months, with 3 months of analysis time (9 months total) | |
Secondary | Body Position and Activity | Does body position and activity affect the quality of the HeartWatch, Event Recorder, and Holter data? | Up to 6 months, with 3 months of analysis time (9 months total) |
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