NCT04300270

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

6.3 years

First QC Date

March 4, 2020

Last Update Submit

March 3, 2025

Conditions

Atrial FibrillationAtrial FlutterArrhythmia

Keywords

SmartphonePhotoplethysmographyCardioversionTelemonitoringValidationMobile ECG

Outcome Measures

Primary Outcomes (1)

  • Performance of the novel smartphone-based photoplethysmographic method for heart rhythm diagnostics and discrimination of atrial fibrillation from normal heart rhythm.

    Sensitivity, specificity, positive predictive value, negative predictive value, receiver operating characteristic (ROC) curve analysis.

    Daily measurements during 30 days

Secondary Outcomes (5)

  • Independent predictors for recurrence of atrial fibrillation within 30 days of treatment with direct current cardioversion.

    30 days

  • Predictors for recurrence of atrial fibrillation within 30 days of treatment with direct current cardioversion using deep learning and machine learning techniques.

    30 days

  • Participant compliance for recording heart rhythm with the novel smartphone-based method twice daily for 30 days.

    30 days

  • Correlation between patient self-reported symptoms and recorded heart rhythm.

    30 days

  • Proportion of same day cancellations for planned treatment of atrial fibrillation with cardioversion for patients using the novel smartphone-based photoplethysmographic method for heart rhythm monitoring prior to the treatment compared to no monitoring.

    2 to 4 weeks

Study Arms (2)

Validation cohort

Participants in validation of the novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics.

Device: Smartphone PPG recordingsDevice: Smartphone ECG

Clinical implementation cohort

Participants in a clinical implementation of the novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics.

Device: Smartphone PPG recordingsDevice: Smartphone ECG

Interventions

Smartphone PPG recordingsDEVICE

Smartphone camera PPG recordings using a novel software application.

Clinical implementation cohortValidation cohort
Smartphone ECGDEVICE

Smartphone connected one-lead ECG recordings.

Also known as: Alivecor Kardia Mobile ECG
Clinical implementation cohortValidation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing direct current cardioversion for treatment of atrial fibrillation or atrial flutter at Danderyd University Hospital.

You may qualify if:

  • Patients undergoing direct current cardioversion successfully for treatment of atrial fibrillation or atrial flutter and have a normal heart rhythm after the treatment.

You may not qualify if:

  • Patients with implantable cardiac devices.
  • Clinical implementation cohort:
  • Patients planned for direct current cardioversion for treatment of atrial fibrillation or atrial flutter.
  • Patients with implantable cardiac devices.
  • Patients with a spontaneous return to sinus rhythm diagnosed at a screening visit 2 to 4 weeks prior to the scheduled treatment with direct current cardioversion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd University Hospital

Stockholm, 182 88, Sweden

Location

Related Publications (1)

  • Fernstad J, Svennberg E, Aberg P, Kemp Gudmundsdottir K, Jansson A, Engdahl J. 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. Europace. 2025 Mar 28;27(4):euaf031. doi: 10.1093/europace/euaf031.

    PMID: 39960451DERIVED

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Engdahl

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

November 27, 2018

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 5, 2025

Record last verified: 2025-03

Locations

SE(1)