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CompletedNCT03234647Updated May 6, 2021

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

An interventional study of Doraya catheter in Acute Heart Failure, sponsored by Revamp Medical Ltd.. Completed at 7 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-05-06.

Sponsored by Revamp Medical Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Heart Failure

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03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 9 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Revamp Medical Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • AHF subjects with poor diuretic response

Exclusion criteria

Exclusion Criteria:

  • AHF subjects with sufficient diuretic response
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    AHF patients

    AHF patient treatment with the Doraya catheter

    Device: Doraya catheter

Interventions

  • DeviceDoraya catheter

    Temporary deployment of the Doraya catheter in AHF patients.

06

What researchers measure

Primary outcomes

  1. Device or procedure related Serious Adverse Event (SAE) rate through 60 days

    SAE as defined by ISO 14155

    Time frame: 60 days

07

Study locations

7 sites
  • Onze-Lieve-Vrouwziekenhuis Aalst
    Aalst, Belgium
  • ZNA Middelheim
    Antwerpen, Belgium
  • Rambam Health Care Campus
    Haifa, Israel
  • Shaare Zedek Medical Center
    Jerusalem, Israel
  • Śląski Uniwersytet Medyczny w Katowicach
    Katowice, Poland
  • 4th Military
    Wrocław, Poland
  • University Hospital
    Wrocław, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03234647
Lead sponsor
Revamp Medical Ltd.
Responsible party
Sponsor
First posted
Jul 31, 2017
Start date
Jan 1, 2018
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
May 6, 2021

Study contacts

Tal Hasin, MD
principal investigator · Shaare Zedek Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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