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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03751904
Other study ID # SIG-0001
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 25, 2019
Est. completion date March 30, 2019

Study information

Verified date January 2019
Source Signature Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 30, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AcoustiCare
Electronic stethoscope

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Signature Medical, Inc.

Outcome

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