Atrial Fibrillation (AF)NCT07212816
Detection of Atrial Fibrillation Through Voice Signal Processing
An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Vital Audio Inc.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Flutter
- What is being tested?
- Sauti
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 30 Nov 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sarah Schwager, RN contact
About this study
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter
- Being tested
- Sauti
- Keywords
- Cardioversion, Irregular Heart Rhythm, Arrhythmia, Atrial Fibrillation, Afib, Artificial Intelligence (AI) in Cardiology, Digital Biomarkers, Voice Biomarkers, Voice Signal Processing, Voice based monitoring
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SautiDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sauti |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Vital Audio Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212816
- Sponsor's protocol ID
- Sonometrik-AFIB-01
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Atrial Fibrillation Through Voice Signal Processing
- ClinicalTrials.gov ID
- NCT07212816
- Acronym / sponsor ID
- Sonometrik-AFIB-01
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter
- Keywords
- Cardioversion, Irregular Heart Rhythm, Arrhythmia, Atrial Fibrillation, Afib, Artificial Intelligence (AI) in Cardiology, Digital Biomarkers, Voice Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vital Audio IncUniversity, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Patients Undergoing Cardioversion | – | Device: SautiInvestigational, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SautiInvestigational, 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 | Atrial Fibrillation Patients Undergoing Cardioversion |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Schwager, RN contact
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Vital Audio Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Buckler, MD, Medical Doctor (2062188750, joshua.buckler@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.