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NCT03234647 Clinical Trial

First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Acute Heart Failure Clinical Trial

Official title:
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03234647
Other study ID # Doraya FIH Study for AHF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date April 30, 2021

Study information
Verified date September 2018
Source Revamp Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

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 diuretic treatment.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - AHF subjects with poor diuretic response Exclusion Criteria: - AHF subjects with sufficient diuretic response

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Doraya catheter
Temporary deployment of the Doraya catheter in AHF patients.

Locations
Country Name City State
Belgium Onze-Lieve-Vrouwziekenhuis Aalst Aalst
Belgium ZNA Middelheim Antwerpen
Israel Rambam Health Care Campus Haifa
Israel Shaare Zedek Medical Center Jerusalem
Poland Slaski Uniwersytet Medyczny w Katowicach Katowice
Poland 4th Military Wroclaw
Poland University Hospital Wroclaw

Sponsors (1)
Lead Sponsor Collaborator
Revamp Medical Ltd.

Countries where clinical trial is conducted

Belgium,  Israel,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Device or procedure related Serious Adverse Event (SAE) rate through 60 days SAE as defined by ISO 14155 60 days
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