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Clinical Trials/NCT03751904
NCT03751904
Withdrawn
N/A

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

Signature Medical, Inc.0 sitesJanuary 25, 2019
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ConditionsHeart Failure，Congestive

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure，Congestive
Sponsor
Signature Medical, Inc.
Primary Endpoint
Incidence of Adverse Events
Status
Withdrawn
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 25, 2019
End Date
March 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Signature Medical, Inc.
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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