NCT03751904

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

November 15, 2018

Last Update Submit

January 25, 2019

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

AcoustiCare

OTHER

Single Arm

Device: AcoustiCare

Interventions

AcoustiCareDEVICE

Electronic stethoscope

AcoustiCare

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 23, 2018

Study Start

January 25, 2019

Primary Completion

February 28, 2019

Study Completion

March 30, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01