First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Sponsor
Revamp Medical Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03234647
Collaborator
(none)
9
7
1
39.9
1.3
0
Study Details
Study Description
Brief Summary
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
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
:
Jan 1, 2018
Actual Primary Completion Date
:
Apr 30, 2021
Actual Study Completion Date
:
Apr 30, 2021
Arms and Interventions
| 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
Primary Outcome Measures
- Device or procedure related Serious Adverse Event (SAE) rate through 60 days [60 days]
SAE as defined by ISO 14155
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- AHF subjects with poor diuretic response
Exclusion Criteria:
- AHF subjects with sufficient diuretic response
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Onze-Lieve-Vrouwziekenhuis Aalst | Aalst | Belgium | ||
| 2 | ZNA Middelheim | Antwerpen | Belgium | ||
| 3 | Rambam Health Care Campus | Haifa | Israel | ||
| 4 | Shaare Zedek Medical Center | Jerusalem | Israel | ||
| 5 | Śląski Uniwersytet Medyczny w Katowicach | Katowice | Poland | ||
| 6 | 4th Military | Wrocław | Poland | ||
| 7 | University Hospital | Wrocław | Poland |
Sponsors and Collaborators
- Revamp Medical Ltd.
Investigators
- Principal Investigator: Tal Hasin, MD, Shaare Zedek Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Revamp Medical Ltd.
ClinicalTrials.gov Identifier:
NCT03234647
Other Study ID Numbers:
- Doraya FIH Study for AHF
First Posted:
Jul 31, 2017
Last Update Posted:
May 6, 2021
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: