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Diagnostic Accuracy in the Detection of Arrhythmias of Patient Recorded ECGs With Smart WATCH TIMEly Performed During Palpitations

NCT06482320 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-07-01

No results posted yet for this study

Summary

Approximately 100 patients with heart palpitations over the age of 22, in possession of smartwatches capable of recording a single-lead ECG will be enrolled.

The study plans to evaluate the performance in the diagnosis of arrhythmia of single-lead ECGs self-recorded by patients during heart palpitations using a smartwatch.

Conditions

Interventions

DIAGNOSTIC_TEST

Recording EKG traces on the smartwatch

Upon enrollment, patients are associated with a progressive identification number (ID). They will then be instructed to record a baseline single-lead EKG (EKG 0) to be sent to a dedicated email address. The sender's email address will be recorded and associated with the ID. The main clinical and demographic data will also be collected. Within 30 days of the enlistment date, a 24-hour EKG Holter will be performed. From the date of enlistment and for the following three months, before, after and during the execution of the 24-hour EKG Holter, enrolled patients can send single-lead EKGs (recorder throug the smartwatch) in case of palpitation. The report of the single-lead EKGs will be communicated electively via e-mail (in response to the email sent by the patient and containing the trace in question) in the following days. In case of diagnostic and/or therapeutic measures to be implemented following the reporting of the trace, doctors will take care of it.

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Matteo Bertini, MD · Ferrara University Hospital

Eligibility

Min Age
22 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-04-01
Completion
2025-10-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482320 on ClinicalTrials.gov