Computerized Stethoscope for Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests special computerized stethoscopes, including the ©CompuSteth and ©VoqX stethoscopes, to determine if they can detect heart problems as effectively as more complex tests like echocardiograms or heart catheterizations. The trial includes individuals already undergoing these heart tests and focuses on those with normal heart sounds or specific conditions such as aortic stenosis (narrowing of the heart's aortic valve) or mitral regurgitation (leakage in the heart's mitral valve). It excludes individuals with unstable heart or lung diseases or multiple valve issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify heart diagnostics.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the computerized stethoscope is safe for heart disease diagnosis?
Research has shown that the VoqX stethoscope safely records heart sounds using advanced technology. One study recorded heart sounds from 100 patients without any safety issues, suggesting the device is generally well-tolerated. The VoqX stethoscope combines electronic components and software to detect heart sounds more effectively. So far, no significant problems have been reported with its use.
This computerized stethoscope aims to match the accuracy of more complex tests like echocardiograms, but without the associated risks. Since the trial compares heart sound recordings to these tests, it does not involve new medicines or invasive tools. Therefore, participants using the VoqX stethoscope face relatively low safety risks.12345Why are researchers excited about this trial?
Researchers are excited about the computerized stethoscope trial because it could transform how heart disease is detected and monitored. Unlike traditional stethoscopes that rely on a doctor's ear, the ©VoqX stethoscope uses advanced technology to record and analyze heart sounds digitally. This could lead to more accurate diagnoses and help identify heart issues earlier by picking up subtle abnormalities that might be missed otherwise. Additionally, the potential for data sharing and analysis through computerized means offers a new layer of insight that could improve patient outcomes significantly.
What evidence suggests that the ©CompuSteth and ©VoqX stethoscopes are effective for detecting heart disease?
Research has shown that the VoqX stethoscope, which uses artificial intelligence, can help detect serious heart problems such as aortic stenosis (a narrowing of the heart's aortic valve). In one study, heart sounds from 100 patients were recorded, and the VoqX successfully identified issues in 50 patients with moderate or severe aortic stenosis. This trial will use computerized auscultation with the VoqX stethoscope, which listens to and analyzes heart sounds instantly, employing advanced technology to improve heart problem detection. Although still under testing, early results suggest it might perform similarly to well-known methods like echocardiograms.23678
Who Is on the Research Team?
Rajiv Gulati, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults who need routine heart checks using echocardiography or cardiac catheterization. It's suitable for those with normal heart sounds, aortic stenosis, or mitral regurgitation. People with unstable heart/lung conditions or multiple valve diseases cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Baseline testing using the ©CompuSteth device to auscultate and record heart sounds at the bedside
Training Phase
Training the ©VoqX device with results from echocardiograms and cardiac catheterization procedures to identify cardiac pathologies
Testing Phase
Testing the ©VoqX device's ability to screen and grade cardiac pathologies in subsequent participants
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- ©CompuSteth stethoscope
- ©VoqX stethoscope
Trial Overview
The study tests the ©VoqX stethoscope that records heart sounds and uses artificial intelligence to detect abnormalities, comparing its results to standard echocardiograms and cardiac catheterizations.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients presenting to the echocardiogram laboratory for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures will undergo a computerized auscultation using the ©VoqX stethoscope and will have their heart sounds auscultated and recorded.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Published Research Related to This Trial
Citations
Artificial Intelligence-Based Stethoscope for the Diagnosis ...
The artificial intelligence-based stethoscope can be used for wide screening of patients for the presence of significant aortic stenosis.
Artificial Intelligence-Based Stethoscope for the Diagnosis ...
In the first stage, using the VoqX, we recorded heart sounds from 100 patients referred for echocardiography (derivation group), 50 with moderate or severe AS ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT04960280/a-study-to-evaluate-a-computerized-stethoscope-called-cvoqx-to-diagnose-heart-diseaseA Study to Evaluate a Computerized Stethoscope Called ...
The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence ...
Computerized Stethoscope for Heart Disease
The CompuSteth and VoqX stethoscopes are unique because they integrate electronic hardware and software to enhance the quality of heart sound detection, ...
Artificial Intelligence-Based Stethoscope for the Diagnosis ...
Real-time heart sounds recordings were performed in the sitting position using an electronic stethoscope (VoqX, Sanolla). For each patient, 5 auscultation ...
Artificial Intelligence-Based Stethoscope for the Diagnosis ...
In the first stage, using the VoqX, we recorded heart sounds from 100 patients referred for echocardiography (derivation group), 50 with ...
Advances in Wearable Stethoscope Technology
This review highlights the potential of wearable electronic stethoscopes to transform cardiovascular health management by enabling early diagnosis and self- ...
AI-Based Stethoscopes Can Accurately, Automatically ...
Artificial intelligence (AI)-based stethoscopes can accurately diagnose left-sided valvular heart disease (VHD), according to original research ...
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