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

Exclusion Criteria

• •1. Any evidence of structural (chordal or leaflet) mitral lesions
• •2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
• •3. Prior mitral valve repair or replacement
• •4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
• •5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
• •6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
• •7. Severe aortic stenosis
• •8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
• •9. Known fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
• •10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
• •11. Congenital heart disease (except PFO, PDA or ASD)
• •12. Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies
• •13. Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy
• •14. Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study
• •15. Any cardiac surgery, within 3 months prior to inclusion in the study
• •16. Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study
• •17. Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3)
• •18. Body temperature \>38°C within 3 days prior to index procedure
• •19. Bleeding disorders or hypercoagulable state
• •20. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
• •21. Contraindication to anticoagulants or antiplatelet agents
• •22. Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated
• •23. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• •24. 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
• •25. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months
• •26. 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
• •27. Pregnancy