Video-based Detection of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: Facial video of detection of cardiac disease

• Registration Number: NCT04267133
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-24
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Disposition First Submitted: 2022-06-07
• Results First Submitted: 2022-11-14
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-10
• Disposition First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Results First Posted: 2023-01-27
• Disposition First Posted: 2023-01-27
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Facial video of detection of cardiac disease	-

Primary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation	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.

Trial Locations

Locations (1)

Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States