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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03751904

Enrollment

Registered

2018-11-23

Start date

2019-01-25

Completion date

2019-03-30

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure，Congestive

Brief summary

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

Interventions

DEVICEAcoustiCare

Electronic stethoscope

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Events	Subjects will be assessed for adverse events through study completion, an average of 1 day	The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026