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

• Sponsor: Signature Medical, Inc. (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03751904
• Collaborator: (none)
• Enrollment: 0
• Arm: 1
• Anticipated Duration (Months): 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure，Congestive	Device: AcoustiCare	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
• Actual Study Start Date: Jan 25, 2019
• Anticipated Primary Completion Date: Feb 28, 2019
• Anticipated Study Completion Date: Mar 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Signature Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Signature Medical, Inc.
• ClinicalTrials.gov Identifier: NCT03751904
• Other Study ID Numbers: SIG-0001
• First Posted: Nov 23, 2018
• Last Update Posted: Jan 29, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 29, 2019