Back to resultsFirst In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Primary Purpose
Acute Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Doraya catheter
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure
Eligibility Criteria
Inclusion Criteria:
- AHF subjects with poor diuretic response
Exclusion Criteria:
- AHF subjects with sufficient diuretic response
Sites / Locations
- Onze-Lieve-Vrouwziekenhuis Aalst
- ZNA Middelheim
- Rambam Health Care Campus
- Shaare Zedek Medical Center
- Śląski Uniwersytet Medyczny w Katowicach
- 4th Military
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AHF patients
Arm Description
AHF patient treatment with the Doraya catheter
Outcomes
Primary Outcome Measures
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
SAE as defined by ISO 14155
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03234647
Brief Title
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Official Title
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revamp Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AHF patients
Arm Type
Experimental
Arm Description
AHF patient treatment with the Doraya catheter
Intervention Type
Device
Intervention Name(s)
Doraya catheter
Intervention Description
Temporary deployment of the Doraya catheter in AHF patients.
Primary Outcome Measure Information:
Title
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
Description
SAE as defined by ISO 14155
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AHF subjects with poor diuretic response
Exclusion Criteria:
AHF subjects with sufficient diuretic response
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Hasin, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze-Lieve-Vrouwziekenhuis Aalst
City
Aalst
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Śląski Uniwersytet Medyczny w Katowicach
City
Katowice
Country
Poland
Facility Name
4th Military
City
Wrocław
Country
Poland
Facility Name
University Hospital
City
Wrocław
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
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