Clinical evaluation of a Smartphone based method for diagnosis of heart rhythm disorders

Reference number
Coordinator Danderyds sjukhus AB - Hjärtkliniken
Funding from Vinnova SEK 700 000
Project duration May 2019 - August 2020
Status Ongoing
Venture Medtech4Health innovators
Call Medtech4Health: Support for Innovators in Care and Healthcare 2019

Purpose and goal

Clinical validation of a photopletysmographic (PPG) smartphone-based recording of the heart rhythm in an out-of-hospital environment. The aim is to study if smartphone-based recording of the heart rhythm will result in a precision comparable to ambulatory handheld ECG recording.

Expected results and effects

We expect that the smartphone-based ECG recordings will have a high degree of agreement with simultaneously ECG recordings. A pilot trial in office environment resulted in a sensitivity of 100% and a specificity of 98,4%. Provided that the validation results in satisfactory performance, availability of heart rhythm diagnostic devices will increase markedly with applications within clinical cardiology and population-based screening.

Planned approach and implementation

We have developed an app for smartphone using recording of the bloodflow in a fingertip by holding the finger in front of the smartphone camera lens, photopletysmography (PPG). The pulsatile bloodflow results in a signal which can be derived to heart rhythm, which will be interpreted by an algorithm. Patients with atrial fibrillation who are waiting for or have undergone electrical cardioversion will be offered to lend a smartphone in order to make multiple ECG and PPG recordings daily during several weeks. The resulting reordings will be compared for diagnostic performance.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 14 May 2019

Reference number 2019-01378

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