Heart Failure With Reduced Ejection FractionPhase 2NCT06851949
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
A Phase 2 study testing Vsling in people with Heart Failure With Reduced Ejection Fraction, run by Cardiac Success at 5 sites in Israel.
Trial summary
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Vsling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesIsrael
- Study dates
- 15 Nov 2024to Apr 2031
- Phase
- Phase 2
- 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
- Age≥18 years
- Left ventricular end diastolic diameter is greater than or equal to 55mm
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
- End-systolic Interpapillary muscle distance ≥ 20mm
- NYHA class II-IVa
- Cardiomyopathy of ischemic or non-ischemic origins
- Understands the nature of the study and procedure and able to provide written informed consent
Who cannot join
- Any evidence of structural (chordal or leaflet) mitral lesions
- Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
- Prior mitral valve repair or replacement
- ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
- Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
- Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
Show all 27Show fewer
- Severe aortic stenosis
- Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
- Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
- ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
- Congenital heart disease (except PFO, PDA or ASD)
- Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies
- Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy
- Any therapeutic invasive cardiac procedure within 30 days prior to index procedure
- Any cardiac surgery, within 3 months prior to inclusion in the study
- Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study
- Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
- Body temperature >38°C within 3 days prior to index procedure
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
- Contraindication to anticoagulants or antiplatelet agents
- Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months
- Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- Pregnancy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Israel5 sites, 5 recruiting
- Not yet recruiting
Shamir Medical Center
Be’er Ya‘aqov
Tami Abudi, +972 (52) 5989833, tami.a@cardiacsuccess.com
Gil Moravski
- Recruiting
Rambam Medical Center
Haifa
Tami Abudi, +972 (52) 5989833, tami.a@cardiacsuccess.com
Arthur Kerner
- Not yet recruiting
Hadassah Medical Center
Jerusalem
Tami Abudi, +972 (52) 5989833, tami.a@cardiacsuccess.com
Planer David
- Not yet recruiting
Rabin Medical Center
Petah Tikva
Tami Abudi, +972 (52) 5989833, tami.a@cardiacsuccess.com
Tuvia Bengal
- Recruiting
Tzafon Medical Center
Poria – Neve Oved
Tami Abudi, +972 (52) 5989833, tami.a@cardiacsuccess.com
Yair Feld
About this study
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
- Being tested
- Vsling
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VslingDevice
Implantable ventricular repair device
| Study group | Role | What they receive |
|---|---|---|
| Vsling | Experimental | Vsling Device implantation Receives: Device: Vsling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related Serious Adverse Events (SAE)
Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiac Success
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851949
- Sponsor's protocol ID
- CL-9003
- Status last verified
- Mar 2026
- First submitted
- 1 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06851949
- Acronym / sponsor ID
- CL-9003
- Keywords
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cardiac SuccessIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 28 Feb 2025 (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.
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vsling | Experimental | Device: VslingVsling Device implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age≥18 years
- Left ventricular end diastolic diameter is greater than or equal to 55mm
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
- End-systolic Interpapillary muscle distance ≥ 20mm
Key exclusion criteria (27 listed)
- Any evidence of structural (chordal or leaflet) mitral lesions
- Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
- Prior mitral valve repair or replacement
- ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
- Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
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 |
|---|---|---|
| VslingImplantable ventricular repair device | Device | Vsling |
Primary outcome
Device related Serious Adverse Events (SAE)
Time frame: 30 Days
Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vsling in people with Heart Failure With Reduced Ejection Fraction, run by Cardiac Success at 5 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 8 inclusion and 27 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tami Abudi, +972 (+972 (52) 5989833, tami.a@cardiacsuccess.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related Serious Adverse Events (SAE) (time frame: 30 Days). 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 28 Oct 2026.