Video-based Detection of Atrial Fibrillation

NCT04267133 | Completed Results FDA Device

• 1 other identifier: 68409
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks

Study Arms (1)

All Participants

EXPERIMENTAL

Diagnostic Test: Facial video of detection of cardiac disease

Interventions

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).

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (22)

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  PMID: 21097349 BACKGROUND

• Dzikowicz DJ, Aktas M, Mykins B, Xia X, Zareba W, Couderc JP. Identifying Demographic Factors Affecting the ECG Duration Collected Using a Single-Lead ECG Patch Device. Ann Noninvasive Electrocardiol. 2025 May;30(3):e70068. doi: 10.1111/anec.70068.

  PMID: 40320720 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

We did not fully enroll the sample size needed to reach statistical significance.

Results Point of Contact

• Title: Jean-Philippe Couderc, PhD
• Organization: University of Rochester

heartjpc@heart.rochester.edu

585-275-1096

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: May 24, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 27, 2023
• Results First Posted: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)