Early Feasibility Study to Assess Safety and Device Perfo... | NCT03751904

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

NCT03751904

Sponsor

Signature Medical, Inc.

Status

Withdrawn

Last Update Posted

Jan 29, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Heart Failure，Congestive

Interventions

AcoustiCare

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor is no longer pursuing the study.

Expanded Access Info

Start Date

Jan 25, 2019Actual

Primary Completion Date

Feb 28, 2019Estimated

Completion Date

Mar 30, 2019Estimated

First Submitted Date

Nov 15, 2018

First Submission Date that Met QC Criteria

Nov 21, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AcoustiCare	Other	Single Arm	Device: AcoustiCare

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AcoustiCare	Device	Electronic stethoscope	AcoustiCare

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects between the ages of 18 - 80 years
Willing and able to sign informed consent form
Normal subjects without a history of heart disease who are recruited from the surrounding community
Subjects with heart failure undergoing treatment in a hospital setting

Exclusion Criteria:

Hemodynamic instability (Systolic BP>180 or <90 and Diastolic BP>90 and <60)
Acute coronary syndrome
Prior heart transplant recipients
Subjects who are pacemaker dependent
Severe obesity (body mass index > 40 kg/m2)
Subjects who are pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided