Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)

Exclusion Criteria

• •1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
• •2. Unstable polymorphic VT or ventricular fibrillation (VF).
• •3. VTs due to any of the following:
• •1. Idiopathic VT
• •2. Automaticity or triggered activity
• •3. Lamin or titin genetic mutation
• •4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
• •4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
• •5. VT or VF thought to be from channelopathies.
• •6. More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
• •7. Sarcoidosis.
• •8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
• •9. Unstable angina.
• •10. Active myocardial ischemia.
• •11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
• •12. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
• •13. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
• •14. Left ventricular ejection fraction (LVEF) \<15%.
• •15. NYHA Class IV heart failure.
• •16. Decompensated heart failure.
• •17. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
• •18. Ventricular assist device (VAD) implanted, planned or required for the procedure.
• •19. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
• •20. Presence of prosthetic valve in the aortic or mitral valve.
• •21. Patients with advanced COPD (on home oxygen).
• •22. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• •23. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
• •24. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
• •25. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).
• •26. Contraindication to anticoagulation.
• •27. End-stage renal disease (requiring dialysis).
• •28. Acute illness, active infection, or sepsis.
• •29. Life expectancy less than 12 months.
• •30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
• •31. Body mass index \>45 kg/m2.
• •32. Known ongoing drug or alcohol dependency.
• •33. Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
• •34. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
• •35. Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.