Acute Heart FailureNCT03234647
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
A study testing Doraya catheter in people with Acute Heart Failure, run by Revamp Medical Ltd. at 7 sites in 3 countries.
Trial summary
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Doraya catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 1 Jan 2018to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHF subjects with poor diuretic response
Who cannot join
- AHF subjects with sufficient diuretic response
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Poland3 sites
Śląski Uniwersytet Medyczny w Katowicach
Katowice
4th Military
Wroclaw
University Hospital
Wroclaw
Israel2 sites
Rambam Health Care Campus
Haifa
Shaare Zedek Medical Center
Jerusalem
About this study
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.
- Conditions
- Acute Heart Failure
- Being tested
- Doraya catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doraya catheterDevice
Temporary deployment of the Doraya catheter in AHF patients.
| Study group | Role | What they receive |
|---|---|---|
| AHF patients | Experimental | AHF patient treatment with the Doraya catheter Receives: Device: Doraya catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
SAE as defined by ISO 14155
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Jan 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revamp Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tal Hasin, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234647
- Sponsor's protocol ID
- Doraya FIH Study for AHF
- Status last verified
- Sep 2018
- First submitted
- 19 Jul 2017
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zymlinski R, Biegus J, Vanderheyden M, Gajewski P, Dierckx R, Bartunek J, Ponikowski P. Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):394-402. doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.
PubMed 37138800
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
- ClinicalTrials.gov ID
- NCT03234647
- Acronym / sponsor ID
- Doraya FIH Study for AHF
- Conditions
- Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Revamp Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHF patients | Experimental | Device: Doraya catheterAHF patient treatment with the Doraya catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AHF subjects with poor diuretic response
Key exclusion criteria (1 listed)
- AHF subjects with sufficient diuretic response
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doraya catheterTemporary deployment of the Doraya catheter in AHF patients. | Device | AHF patients |
Primary outcome
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
Time frame: 60 days
SAE as defined by ISO 14155
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 37138800Zymlinski R, Biegus J, Vanderheyden M, Gajewski P, Dierckx R, Bartunek J, Ponikowski P. Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):394-402. doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tal Hasin, MD principal investigator
Shaare Zedek Medical Center
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doraya catheter in people with Acute Heart Failure, run by Revamp Medical Ltd. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device or procedure related Serious Adverse Event (SAE) rate through 60 days (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.