NCT04300270

Validation of a Novel Smartphone-based Method for Heart Rhythm Monitoring in the Home Environment

Active, enrolled Last updated 5 March 2025

What this trial tests

trial testing Smartphone PPG recordings in Atrial Fibrillation in 480 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 November 2018

Primary endpoint
1 April 2025

1 April 2025

Quick facts

Lead sponsor	Karolinska Institutet
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	480
Start date	27 November 2018
Primary completion	1 April 2025
Estimated completion	1 April 2025
Sites	1 location across Sweden

Drugs / interventions tested

• Smartphone PPG recordings
• Smartphone ECG

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Atrial Flutter — all drugs for Atrial Flutter →
• Arrhythmia — all drugs for Arrhythmia →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation is a heart rhythm disorder with increased risk of stroke, heart failure, dementia and death. The severity of symptoms in atrial fibrillation varies markedly, ranging from no symptoms to those with disabling symptoms. An ECG recording is currently mandatory for diagnosing atrial fibrillation. A portable method for heart rhythm diagnostics that is readily available is currently missing in clinical practice. If a standard smartphone could be used for heart rhythm diagnostics, the availability could improve greatly.

Treatment with direct current cardioversion is a procedure in which the heart rhythm is normalized by an electrical shock through the chest. Patients with atrial fibrillation are in some cases recommended treatment with direct current cardioversion but the procedure is costly, has a high recurrence rate and includes an increased risk for stroke. In this study we will validate the use of a novel smartphone-based method for heart rhythm diagnostics when used by patients in their home environment. The novel method is using the smartphone camera as a sensor. Patients will be doing heart rhythm measurements with the novel smartphone-based method in their home environment for 30 days after successfully receiving treatment of atrial fibrillation with direct current cardioversion. The novel smartphone-based method will be validated against simultaneous recordings with mobile ECG.

We will also study the feasibility in using smartphone recordings and mobile ECG in the home environment the weeks before receiving treatment with direct current cardioversion, to study the possible benefit of detecting spontaneous conversions to normal heart rhythm and missed doses of treatment with blood thinning medication, both of which will lead to cancellation or detention of the cardioversion procedure.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Validation of a novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics: the SMARTBEATS study.
   Fernstad J, Svennberg E, Åberg P, Kemp Gudmundsdottir K, et al · · 2024 · cited 8× · PMID 38533836 · DOI 10.1093/europace/euae079
2. External validation of a machine learning-based classification algorithm for ambulatory heart rhythm diagnostics in pericardioversion atrial fibrillation patients using smartphone photoplethysmography: the SMARTBEATS-ALGO study.
   Fernstad J, Svennberg E, Åberg P, Kemp Gudmundsdottir K, et al · · 2025 · cited 3× · PMID 39960451 · DOI 10.1093/europace/euaf031
3. Precardioversion Heart Rhythm Monitoring Using Smartphone Photoplethysmography: The SMARTBEATS Randomized Clinical Trial.
   Fernstad J, Svennberg E, Åberg P, Engdahl J. · · 2026 · PMID 42234449 · DOI 10.1001/jamacardio.2026.1269