Clinical trial NCT04267133: Video-based Detection of Atrial Fibrillation
Official title: Home-based Videoplethysmographic Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-02-12
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
Study officials:
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