Status:
COMPLETED
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Lead Sponsor:
Revamp Medical Ltd.
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
Detailed Description
The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to d...
Eligibility Criteria
Inclusion
- AHF subjects with poor diuretic response
Exclusion
- AHF subjects with sufficient diuretic response
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03234647
Start Date
January 1 2018
End Date
April 30 2021
Last Update
May 6 2021
Active Locations (7)
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1
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Belgium
2
ZNA Middelheim
Antwerp, Belgium
3
Rambam Health Care Campus
Haifa, Israel
4
Shaare Zedek Medical Center
Jerusalem, Israel