Detection of Atrial Fibrillation Through Voice Signal Processing

NCT07212816 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Sonometrik-AFIB-01
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Atrial Flutter

Keywords

Cardioversion; Irregular Heart Rhythm; Arrhythmia; Atrial Fibrillation; Afib; Artificial Intelligence (AI) in Cardiology; Digital Biomarkers; Voice Biomarkers; Voice Signal Processing; Voice based monitoring

Outcome Measures

Primary Outcomes (2)

• 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.

  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 cardioversion

• 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

  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 cardioversion

Study Arms (1)

Atrial Fibrillation Patients Undergoing Cardioversion

Investigational, 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.

Device: Sauti

Interventions

Sauti DEVICE

Investigational, 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.

Atrial Fibrillation Patients Undergoing Cardioversion

Eligibility Criteria

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

Study 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.

You may qualify if:

• Diagnosis of atrial fibrillation and presenting for cardioversion at Allina Health in atrial fibrillation
• \. ≥ 18 years of age Written informed consent obtained from patient in English

You may not qualify if:

• Patients who meet any of the following criteria must be excluded from this study:
• History of a pacemaker
• History of dysphasia or difficulty with word finding
• History of vocal cord dysfunction
• Patient with atrial flutter as presenting arrhythmia
• Planned transesophageal echocardiogram (TEE) with cardioversion

Sponsors & Collaborators

• Vital Audio Inc: lead
• Minneapolis Heart Institute Foundation: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joshua Buckler, MD, Medical Doctor

CONTACT

2062188750; joshua.buckler@allina.com

Sarah Schwager, RN

CONTACT

sarah.schwager@allina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 30, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10