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

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

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure，Congestive
• Intervention / Treatment: Device: AcoustiCare

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AcoustiCare; Single Arm	Device: AcoustiCare; Electronic stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Signature Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): March 30, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SIG-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No