Detection of Atrial Fibrillation Through Voice Signal Processing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVital Audio Inc
About this trial
This study is testing a new technology that listens to a person's voice during short phone calls to help identify heart rhythm problems. The goal is to see if voice signal analysis can tell the difference between a normal rhythm (sinus rhythm) and an irregular rhythm (atrial fibrillation).
We are enrolling adults scheduled for a standard heart procedure called cardioversion, which is used to reset the heart to a normal rhythm. Each participant will provide voice recordings through three short phone calls: before cardioversion, just after the procedure, and at a follow-up visit. Results will be compared with standard heart rhythm tests (electrocardiograms or ECGs).
This research may lead to a simple, low-cost way to monitor heart rhythms remotely without requiring special devices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of atrial fibrillation and presenting for cardioversion at Allina Health in atrial fibrillation
3. ≥ 18 years of age Written informed consent obtained from patient in English
Disqualifiers
History of a pacemaker
History of dysphasia or difficulty with word finding
History of vocal cord dysfunction
Patient with atrial flutter as presenting arrhythmia
Trial population
Adults (≥18 years) with a diagnosis of atrial fibrillation scheduled for elective direct-current cardioversion at the Minneapolis Heart Institute Foundation (Abbott Northwestern Hospital). Eligible patients are identified by research staff via EMR pre-screening of cardioversion/procedure and clinic schedules and by provider referral; written informed consent in English is obtained prior to the procedure. Key exclusions: prior pacemaker; dysphasia or word-finding difficulty; vocal cord dysfunction; atrial flutter as the presenting arrhythmia; planned transesophageal echocardiogram (TEE) with cardioversion. No upper age limit. Single-center, single-cohort; no biospecimens collected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sauti
DeviceInvestigational, software-only device that acquires short voice samples during automated phone calls and analyzes cardiopulmonary signals to estimate heart rate (HR), heart-rate variability (HRV), and rhythm status (regular vs irregular). In this study, three calls are initiated via the Vital Audio web platform (pre-, post-cardioversion, and 1-month follow-up). Results are available only to study staff and are compared with ECG obtained at the same time points. The device is used for data collection/assessment only and does not guide clinical care. IDE: G230147.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Atrial Fibrillation Patients Undergoing Cardioversion1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of voice-based rhythm classification vs ECG
Percentage of Vital Audio (Sauti v1.0) rhythm classifications (regular vs irregular) that match the ECG-determined rhythm at the same time point. Participants serve as their own controls. Results are aggregated across the three time points; 95% confidence intervals will be reported.
Time frame
Pre-cardioversion (same day), post-cardioversion before discharge (same day), and follow-up at 1 week-1 month post-procedure; overall up to 1 month after cardioversion2
Accuracy of voice-based rhythm classification vs ECG
Percentage of Vital Audio (Sauti v1.0) rhythm classifications (regular vs irregular) that match the ECG-determined rhythm at the same time point. Participants serve as their own controls. Results are aggregated across the three time points; 95% confidence intervals will be reported
Time frame
Pre-cardioversion (same day), post-cardioversion before discharge (same day), and follow-up at 1 week-1 month post-procedure; overall up to 1 month after cardioversionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vital Audio Inc
Lead sponsor
Minneapolis Heart Institute Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: