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

Heart Failure,Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03751904
• Other study ID #: SIG-0001
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

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