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

May 4, 2021 updated by: Revamp Medical Ltd.
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHF subjects with poor diuretic response

Exclusion Criteria:

  • AHF subjects with sufficient diuretic response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AHF patients
AHF patient treatment with the Doraya catheter
Device: Doraya catheter
Temporary deployment of the Doraya catheter in AHF patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
Time Frame: 60 days
SAE as defined by ISO 14155
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revamp Medical Ltd.

Investigators

  • Principal Investigator: Tal Hasin, MD, Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (ACTUAL)

July 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doraya FIH Study for AHF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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