Status:
WITHDRAWN
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
Lead Sponsor:
Signature Medical, Inc.
Conditions:
Heart Failure，Congestive
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03751904
Start Date
January 25 2019
End Date
March 30 2019
Last Update
January 29 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.