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

Primary Purpose

Heart Failure，Congestive

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcoustiCare
Sponsored by
Signature Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure，Congestive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    AcoustiCare

    Arm Description

    Single Arm

    Outcomes

    Primary Outcome Measures

    Incidence of Adverse Events
    The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2018
    Last Updated
    January 25, 2019
    Sponsor
    Signature Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03751904
    Brief Title
    Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
    Official Title
    Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor is no longer pursuing the study.
    Study Start Date
    January 25, 2019 (Actual)
    Primary Completion Date
    February 28, 2019 (Anticipated)
    Study Completion Date
    March 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Signature Medical, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure，Congestive

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AcoustiCare
    Arm Type
    Other
    Arm Description
    Single Arm
    Intervention Type
    Device
    Intervention Name(s)
    AcoustiCare
    Intervention Description
    Electronic stethoscope
    Primary Outcome Measure Information:
    Title
    Incidence of Adverse Events
    Description
    The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study
    Time Frame
    Subjects will be assessed for adverse events through study completion, an average of 1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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