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Video-based Detection of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facial video of detection of cardiac disease
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Strong Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
January 10, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04267133
Brief Title
Video-based Detection of Atrial Fibrillation
Official Title
Home-based Videoplethysmographic Detection of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Facial video of detection of cardiac disease
Intervention Description
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 Outcome Measure Information:
Title
Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Video-based Detection of Atrial Fibrillation

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