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

NCT03234647 — Not applicable, Completed, 9 participants, Revamp Medical Ltd.
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RegistryNCT03234647
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment9 (Actual)
SponsorRevamp Medical Ltd. (Industry)
ConditionsAcute Heart Failure
InterventionsDoraya catheter (Device)
Datesstart 2018-01-01, primary completion 2021-04-30, completion 2021-04-30, first posted 2017-07-31, last updated 2021-05-06
Locations7 sites in Belgium, Israel, Poland

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-Summary

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

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+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 diuretic treatment.

+Arms and interventions

ArmTypeInterventionsDescription
AHF patientsExperimentalDevice: Doraya catheterAHF patient treatment with the Doraya catheter
  • Doraya catheter (Device): Temporary deployment of the Doraya catheter in AHF patients.

+Outcome measures

Primary outcomes

  • Device or procedure related Serious Adverse Event (SAE) rate through 60 days [60 days]: SAE as defined by ISO 14155

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* AHF subjects with poor diuretic response

Exclusion Criteria:

* AHF subjects with sufficient diuretic response

+Locations (7)

FacilityCityCountryStatus
Onze-Lieve-Vrouwziekenhuis AalstAalstBelgium
ZNA MiddelheimAntwerpBelgium
Rambam Health Care CampusHaifaIsrael
Shaare Zedek Medical CenterJerusalemIsrael
Śląski Uniwersytet Medyczny w KatowicachKatowicePoland
4th MilitaryWroclawPoland
University HospitalWroclawPoland

+Publications

  • Results publication: 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. PMID 37138800

+Investigators

  • Tal Hasin, MD, Principal investigator, Shaare Zedek Medical Center

My Notes