Tests the Vsling device to repair the heart's pumping chamber
Tests the Vsling device in adults with heart failure and a weakened, enlarged heart.
Plain-language title generated from the registry record
Registry title: Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Key facts
- Where
- Krakow, PolandSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure and a weak, enlarged left heart chamber, to test the Vsling device for ventricular repair.
- Age
- 18 to under 85 years
- Sex
- All sexes can join.
- Disease stage
- Heart failure with ejection fraction 20% to 40%; left ventricle end-diastolic diameter at least 55mm; mitral leak no worse than mild (FMR grade 2+ or less); NYHA class II-IVa; ischemic or non-ischemic cardiomyopathy.
- Earlier treatment
- No prior mitral valve repair or replacement. No heart surgery within 3 months and no invasive heart procedure within 30 days before joining.
- Biomarker or test result
- End-systolic interpapillary muscle distance at least 20mm.
Main reasons for not taking part
- Structural mitral valve damage (chordal or leaflet)
- Ventricular tachycardia or fibrillation within 6 months
- Heart attack with ST elevation within 30 days, or cardiogenic shock within 30 days
- Severe kidney problems (creatinine 3.0 mg/dL (265 µmol/L) or higher, or long-term dialysis)
- Pregnancy
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06002386, who can take part
Where in Poland
- John Paull II HospitalKrakow, PolandContact: Piotr Musialek, Prof.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Cardiac Success
- Trial code
- NCT06002386
- Record updated
- 28 October 2026
- Original description
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 full original descriptionShow less
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
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.
Inclusion: Age≥ 18 and < 85 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.
Exclusion: 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; Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair; ST segment elevation myocardial infarction within 30 days prior to inclusion in this study; Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study; Any cardiac surgery, within 3 months prior to inclusion in the study; Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study; Body temperature >38°C within 3 days prior to index procedure; 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; Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy; Congenital heart disease (except PFO, PDA or ASD); Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies; Bleeding disorders or hypercoagulable state; Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant; 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; 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; Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy; Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3); Any evidence of structural (chordal or leaflet) mitral lesions; Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s); Severe aortic stenosis; Contraindication to anticoagulants or antiplatelet agents; Pregnancy.