Tests the Vsling device to repair the heart in heart failure

Trial details

Who runs it

Cardiac Success

Trial code

NCT06851949

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™ I: 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 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 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; 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.

ClinicalTrials.gov NCT06851949