Acute Decompensated Heart FailureNCT05759806
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
A study testing Nephronyx system (Perfuser) in people with Acute Decompensated Heart Failure, run by Nephronyx LTD at 4 sites in Israel.
Trial summary
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Nephronyx system (Perfuser)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesIsrael
- Study dates
- 19 Dec 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to the hospital with a primary diagnosis of ADHF
- Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
- Patient with Left Ventricular Ejection Fraction LVEF >15%
- Patient has compromised response to diuretics
- NT-proBNP >450 pg/mL if aged <55 years, >900 pg/mL if aged between 55 and 75 years and >1800 pg/mL if aged >75 years
Who cannot join
- Patient with active DVT or history of DVT
- Patient has documented or evidence of Renal artery stenosis
- BMI>35 Kg/m^2
- Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
- Patient is in Cardiogenic shock
- Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
- Temperature > 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
- Patient has shown liver cirrhosis or has signs of liver damage
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel4 sites, 4 recruiting
- Recruiting
Rambam Medical Center
Haifa
Amir Solomonica, MD, a_solomonica@rambam.health.gov.il
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Shemy Carasso, MD, +972-2-5645646, shemyca@szmc.org.il
- Recruiting
The Baruch Padeh Medical Center, Poriya
Poria Illit
Wadi Kinany, MD, WKinany@poria.health.gov.il
- Recruiting
Kaplan Medical Center
Rehovot
Sorel Goland, MD, +972-8-9440070, Sorel_G@clalit.org.il
About this study
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Nephronyx system (Perfuser)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephronyx system (Perfuser)Device
Also called The Nephronyx system (Perfuser)
Temporary deployment of the Nephronyx system (Perfuser)
| Study group | Role | What they receive |
|---|---|---|
| ADHF patients | Experimental | ADHF patients with compromised response to diuretics treated with Nephronyx system Receives: Device: Nephronyx system (Perfuser) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Device and/or investigational procedure related SAEs
Measured: 24 hours post device retrieval
Performance/ Procedural success
Device preforms as planned with no associated device malfunction
Measured: procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start19 Dec 2022
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nephronyx LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Aronson, MD, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759806
- Sponsor's protocol ID
- CLD-NPX-085
- Status last verified
- May 2025
- First submitted
- 26 Feb 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
- ClinicalTrials.gov ID
- NCT05759806
- Acronym / sponsor ID
- CLD-NPX-085
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nephronyx LTDIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Mar 2023 (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.
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHF patients | Experimental | Device: Nephronyx system (Perfuser)ADHF patients with compromised response to diuretics treated with Nephronyx system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient admitted to the hospital with a primary diagnosis of ADHF
- Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
- Patient with Left Ventricular Ejection Fraction LVEF >15%
- Patient has compromised response to diuretics
- NT-proBNP >450 pg/mL if aged <55 years, >900 pg/mL if aged between 55 and 75 years and >1800 pg/mL if aged >75 years
Key exclusion criteria (8 listed)
- Patient with active DVT or history of DVT
- Patient has documented or evidence of Renal artery stenosis
- BMI>35 Kg/m^2
- Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
- Patient is in Cardiogenic shock
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 |
|---|---|---|
| Nephronyx system (Perfuser)Also: The Nephronyx system (Perfuser)Temporary deployment of the Nephronyx system (Perfuser) | Device | ADHF patients |
Primary outcome
Serious Adverse Events
Time frame: 24 hours post device retrieval
Device and/or investigational procedure related SAEs
Performance/ Procedural success
Time frame: procedure day
Device preforms as planned with no associated device malfunction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Doron Aronson, MD study director
Rambam Health Care Campus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nephronyx system (Perfuser) in people with Acute Decompensated Heart Failure, run by Nephronyx LTD at 4 sites in Israel.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sagy Karavany (972-8-9999734, sagy@nephronyx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 24 hours post device retrieval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.