First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
NCT ID: NCT03234647
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2018-01-01
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AHF patients
AHF patient treatment with the Doraya catheter
Doraya catheter
Temporary deployment of the Doraya catheter in AHF patients.
Interventions
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Doraya catheter
Temporary deployment of the Doraya catheter in AHF patients.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Revamp Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tal Hasin, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center
Locations
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Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Śląski Uniwersytet Medyczny w Katowicach
Katowice, , Poland
4th Military
Wroclaw, , Poland
University Hospital
Wroclaw, , Poland
Countries
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References
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Zymlinski R, Biegus J, Vanderheyden M, Gajewski P, Dierckx R, Bartunek J, Ponikowski P. Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):394-402. doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.
Other Identifiers
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Doraya FIH Study for AHF
Identifier Type: -
Identifier Source: org_study_id
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