Video-based Detection of Atrial Fibrillation

The project focuses on the evaluation of a novel, contactless monitoring technology to measure the blood pulsatile signal based on the video recording of an individual's face. The variability of the pulse rate is computed to identify the presence of atrial fibrillation (AF). We propose to enroll 315 patients with symptomatic AF, paroxysmal or persistent, who go through successful radiofrequency ablation or electrical cardioversion. A computer tablet will be used by the subjects at home during 14 days after their procedure to read emails, browse the internet and watch videos. Facial video recordings will be automatically acquired during these daily activities by the tablet device. The subject will be wearing an ECG patch during the follow-up period. The one-lead continuous ECG will be used as a reference to verify the presence of AF rhythm during facial video recordings. The primary aim of the study is to demonstrate the validity and robustness of the video-based technology to detect the presence of AF when facial videos are acquired by the patients at home.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women older than 18 years of age,
Medically-managed for symptomatic AF (persistent or paroxysmal),
In sinus rhythm after their ablation procedure,
In sinus rhythm after trans-thoracic electrical cardioversion.

Exclusion criteria

Implanted with a device (pacemaker, CRT, ICD) and a ventricular pacing requirement superior or equal to 70%,
Known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies,
Unable to cooperate with the protocol due to dementia, psychological, or other related reason,
Refusing to sign the consent for participation,
Unable to operate the device such as blind patients.
Patients with Parkinson disease (or other central nervous system disorder/Tremor) who cannot record a stable video signal of their face.
The subject was previously enrolled in the current study.
The subject wears clothing covering the face, or uses facial makeup that will interfere with the quality of facial recordings.
Subject does not have internet access at home and lacks the technology to participate.

Treatment and study plan

Facial video of detection of cardiac disease

Diagnostic Test

This project proposes to evaluate a non-contact video recording technology to detect the presence of AF. The technology extracts a pulsatile signal by measuring the subtle variations in skin color of a patient's face (flushing) due to the variations of blood volume underneath the skin. The technology uses a standard web camera. This technique is videoplethysmography (VPG).

Primary outcomes

Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation

Time frame: 2 weeks

The outcome measure is the AUC of the curve obtained from the ROC analysis. The curve is a combination of specificity and sensitivity of detecting atrial fibrillation. The range of the curve is 0.5-1.0 where 0.5 would be random detection of atrial fibrillation and 1.0 would be perfect performance.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

Home-based Videoplethysmographic Detection of Atrial Fibrillation

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Feb 12, 2020
Registry last updated: Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed