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

Not Applicable

Withdrawn

• Conditions: Heart Failure，Congestive

• Registration Number: NCT03751904
• Lead Sponsor: Signature Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Status Verified: 2019-01
• Study Start: 2019-01-25
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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