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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03234647
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Revamp Medical Ltd.

Study Description
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Brief Summary:
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Device: Doraya catheter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Device or procedure related Serious Adverse Event (SAE) rate through 60 days [ Time Frame: 60 days ]
    SAE as defined by ISO 14155


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AHF subjects with poor diuretic response

Exclusion Criteria:

  • AHF subjects with sufficient diuretic response
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234647


Locations
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Belgium
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Belgium
ZNA Middelheim
Antwerpen, Belgium
Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Poland
Śląski Uniwersytet Medyczny w Katowicach
Katowice, Poland
4th Military
Wrocław, Poland
University Hospital
Wrocław, Poland
Sponsors and Collaborators
Revamp Medical Ltd.
Investigators
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Principal Investigator: Tal Hasin, MD Shaare Zedek Medical Center
More Information
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Responsible Party: Revamp Medical Ltd.
ClinicalTrials.gov Identifier: NCT03234647    
Other Study ID Numbers: Doraya FIH Study for AHF
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases