An observational study in Atrial Fibrillation (AF) and Atrial Flutter, sponsored by Vital Audio Inc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Vital Audio Inc · Observational
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 40 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Vital Audio Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To participate in this study, patients must meet all of the following inclusion criteria:
Exclusion Criteria:
Patients who meet any of the following criteria must be excluded from this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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 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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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