Using smartwatches to detect arrhythmias during heart palpitations

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

This study is testing if smartwatches can help people with heart palpitations accurately detect different types of irregular heartbeats, especially atrial fibrillation.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 22 Years to 100 Years
• Sex: All
• Sponsor: University Hospital of Ferrara (other)
• Locations: 1 site (Ferrara)
• Trial ID: NCT06482320 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the diagnostic accuracy of single-lead ECGs recorded by patients using smartwatches during episodes of heart palpitations. Approximately 100 patients over the age of 22 will be enrolled, all of whom must own a compatible smartwatch. The study will collect clinical and electrocardiographic data from these patients as they report to outpatient clinics. The goal is to determine how effectively these self-recorded ECGs can identify various types of arrhythmias, particularly atrial fibrillation.

Who should consider this trial

Good fit: Ideal candidates are patients aged 22 and older who experience heart palpitations and own a smartwatch capable of recording ECGs.

Not a fit: Patients under 22 years of age or those with implanted cardiac devices such as ICDs or pacemakers will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a cost-effective and accessible method for diagnosing arrhythmias in patients experiencing palpitations.

How similar studies have performed: While the use of smartwatches for ECG recording is gaining popularity, this specific approach to diagnosing arrhythmias through patient-recorded data is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Patients 22 years of age and older
3. Patients able to send recorded traces in PDF format by e-mail.
4. Signature of consent

Exclusion Criteria:

1. Under 22 years of age
2. Carriers of ICDs, S-ICDs, pacemakers, loop recorders.
3. Known left bundle branch block although frequency dependent on a previous baseline ECG or Holter ECG
4. 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
5. State of pregnancy;

Where this trial is running

Ferrara

• Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (RECRUITING)

Study contacts

• Principal investigator: Matteo Bertini, MD — Ferrara University Hospital
• Study coordinator: Matteo Bertini, MD

Conditions: Arrhythmia, smartwatch, palpitation