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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03751904
Recruitment Status : Withdrawn (Sponsor is no longer pursuing the study.)
First Posted : November 23, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Signature Medical, Inc.

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 25, 2019
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
AcoustiCare
Single Arm
 Device: AcoustiCare
Electronic stethoscope


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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No Contacts or Locations Provided
More Information
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Responsible Party: Signature Medical, Inc.
ClinicalTrials.gov Identifier: NCT03751904    
Other Study ID Numbers: SIG-0001
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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