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

Signature Medical

Status: Withdrawn

Conditions: Heart Failure，Congestive

Treatments: Device: AcoustiCare

Study type: Interventional

Funder types: Other

Identifiers

NCT03751904

SIG-0001

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

AcoustiCare

Other group

Description:

Single Arm

Treatment:

Device: AcoustiCare