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

Not Applicable

Withdrawn

• Conditions: Heart Failure，Congestive
• Interventions: Device: AcoustiCare

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
AcoustiCare	AcoustiCare	Single Arm

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