Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

NCT ID: NCT04292405

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2025-09-30

Brief Summary

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Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.

Detailed Description

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Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure Patients

Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM

Wearable Cardioverter Defibrillator

Intervention Type DEVICE

Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.

Interventions

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Wearable Cardioverter Defibrillator

Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.

Intervention Type DEVICE

Other Intervention Names

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AUDICOR AM

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* heart failure or a history of heart failure
* ischemic or non-ischemic cardiomyopathy
* ejection Fraction less than or equal to 40% as measured within the last 6 months

Exclusion Criteria

* implanted left ventricular assist device
* pacemaker dependency
* currently hospitalized
* atrial fibrillation on their last ECG or having an irregularly irregular pulse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Osz

Role: STUDY_DIRECTOR

Director, Clinical Operations, ZOLL

Locations

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MAYO Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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90d0214

Identifier Type: -

Identifier Source: org_study_id

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