Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2019-03-30

Brief Summary

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AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.

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Detailed Description

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Conditions

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Heart Failure，Congestive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AcoustiCare

Single Arm

Group Type OTHER

AcoustiCare

Intervention Type DEVICE

Electronic stethoscope

Interventions

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AcoustiCare

Electronic stethoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects between the ages of 18 - 80 years
2. Willing and able to sign informed consent form
3. Normal subjects without a history of heart disease who are recruited from the surrounding community
4. Subjects with heart failure undergoing treatment in a hospital setting

Exclusion Criteria

1. Hemodynamic instability (Systolic BP\>180 or \<90 and Diastolic BP\>90 and \<60)
2. Acute coronary syndrome
3. Prior heart transplant recipients
4. Subjects who are pacemaker dependent
5. Severe obesity (body mass index \> 40 kg/m2)
6. Subjects who are pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes