CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
Facial video of detection of cardiac diseaseother
Likely dose
Not stated in record
Key inclusion· 4
  • Age >18 years
  • Medically-managed symptomatic AF (persistent or paroxysmal)
  • Currently in sinus rhythm after ablation procedure
  • Currently in sinus rhythm after electrical cardioversion
Key exclusion· 8
  • Implanted device with ≥70% ventricular pacing requirement
  • Allergy to adhesives or hydrogels, or family history of adhesive skin allergies
  • Unable to cooperate due to dementia, psychological, or related reason
  • Parkinson disease or CNS disorder/tremor preventing stable facial video recording

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04267133
NCT04267133N/ACompleted

Home-based Videoplethysmographic Detection of Atrial Fibrillation

University of Rochester·interventional·Posted Feb 12, 2020·Updated Jan 27, 2023

In Brief

A clinical study evaluating Facial video of detection of cardiac disease for Atrial Fibrillation. Completed, enrolled 256 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 12, 2020
Enrollment StartMay 24, 2018
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.4 years ago

Interventions

Facial video of detection of cardiac diseaseother

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).