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

NCT06482320 | Unknown DMC

• 1 other identifier: 111/2023/Oss/AOUFe
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Arrhythmia

Keywords

smartwatch; Arrhythmia; palpitation

Outcome Measures

Primary Outcomes (2)

• Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch.

  Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch

  3 month after the enrollment

• Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter)

  Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter)

  3 month after the enrollment

Secondary Outcomes (2)

• Compare the accuracy of automatic AF detection of the Watch versus a cardiologist interpretation of a 12-lead ECG (gold-standard)

  3 month after the enrollment

• evel of agreement of measured interval duration between the Watch 1-lead ECG and a 12-lead ECG.

  3 month after the enrollment

Study Arms (1)

Study Group

Adults aged between 22 and 70 years and owners of smartwatch capable of EKG recording referred at the ER, Cardiology ward or Cardiology Clinic for palpitation are eligible according to the inclusion criteria.

Diagnostic Test: Recording EKG traces on the smartwatch

Interventions

Recording EKG traces on the smartwatch DIAGNOSTIC_TEST

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.

Study Group

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 22 years or over referring to the outpatient clinics of the participating centers for heart palpitations, owners of Smart Watches capable of recording ECGs.

You may qualify if:

• Patients attending the outpatient clinics of the participating heart palpitations owners of smartwatches and mobile phones capable of recording a single-lead ECG on request
• Patients 22 years of age and older
• Patients able to send recorded traces in PDF format by e-mail.
• Signature of consent

You may not qualify if:

• Under 22 years of age
• Carriers of ICDs, S-ICDs, pacemakers, loop recorders.
• Known left bundle branch block although frequency dependent on a previous baseline ECG or Holter ECG
• Known right bundle branch block with QRS duration greater than or equal to 120 ms even if frequency dependent on a previous baseline ECG or Holter ECG
• State of pregnancy;

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Bertini, MD

  Ferrara University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Bertini, MD

CONTACT

0532236269; doc.matber@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)