Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure

Ki vehet részt

• 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

Ki nem vehet részt

• 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