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Detection of Atrial Fibrillation Through Voice Signal Processing

NCT07212816 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    collaborator OTHER

  • Vital Audio Inc

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2025-11-15
Completion
2025-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212816 on ClinicalTrials.gov