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NCT Number: NCT07212816

Detection of Atrial Fibrillation Through Voice Signal Processing

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.

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Key information

About this study

This is a prospective, single-center cohort study of 40 patients undergoing cardioversion for atrial fibrillation at the Minneapolis Heart Institute Foundation. The study is designed to evaluate whether Vital Audio's investigational vocal biomarker software can reliably distinguish between regular (sinus) and irregular (atrial fibrillation) heart rhythms.

Participants will serve as their own controls. They will complete three structured voice recordings: pre-cardioversion, immediately after cardioversion, and at a follow-up visit (1 week to 1 month later). At each time point, ECG data will be collected as the reference standard. Voice samples will be captured through automated phone calls initiated via the Vital Audio platform, with each call lasting about one minute.

The software analyzes short vowel sounds in real time to extract heart rate, heart rate variability, and rhythm classification (regular vs. irregular). Data are stored securely, and results are available only to study staff. Patients and their providers will not receive study results directly.

The study is minimal risk, with no cost to participants. Compensation is provided for participation. While individuals may not personally benefit, the study aims to generate feasibility data on voice-based heart rhythm monitoring, potentially reducing reliance on costly consumer devices or frequent clinic visits. Findings will support future large-scale trials and may contribute to improved remote monitoring strategies for atrial fibrillation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To participate in this study, patients must meet all of the following inclusion criteria:

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Accuracy of voice-based rhythm classification vs ECG

    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 cardioversion

    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.

  2. Accuracy of voice-based rhythm classification vs ECG

    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 cardioversion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Buckler, MD, Medical Doctor

CONTACT

[email protected]

2062188750

Sarah Schwager, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vital Audio Inc

Other

Collaborators

  • Minneapolis Heart Institute Foundation

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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