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

Eligibility Criteria

• 1. Prior myocardial infarction.
• 2. At least one episode of sustained (continuous for \>30 seconds, or requiring implantable cardiac defibrillator intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
• 3. Spontaneous occurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or implantable cardiac defibrillator intervention.
• 4. Implanted with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator for at least 3 months prior to the ablation procedure.
• 5. Age 18 through 85 years old.
• 6. Willing and able to provide informed consent.
• 7. Willing and able to comply with all pre-, post-, and follow-up testing requirements.
• 1. Incessant ventricular tachycardia necessitating hemodynamic support prior to the ablation procedure.
• 2. Unstable polymorphic ventricular tachycardia or ventricular fibrillation.
• 3. Idiopathic ventricular tachycardia or ventricular tachycardia of non-ischemic cardiomyopathy.
• 4. Known reversible cause of ventricular tachycardia (e.g., electrolyte abnormalities, drug induced arrhythmia).
• 5. Ventricular tachycardia or ventricular fibrillation thought to be from channelopathies.
• 6. More than one prior ventricular tachycardia ablation at any time, or any ventricular tachycardia ablation within 6 months prior to the ablation procedure.
• 7. Unstable angina.
• 8. Active myocardial ischemia.
• 9. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
• 10. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
• 11. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
• 12. Left ventricular ejection fraction \<15%.
• 13. New York Heart Association Class IV heart failure.
• 14. Decompensated heart failure.
• 15. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation.
• 16. Ventricular assist device implanted, planned or required for the procedure.
• 17. Severe aortic stenosis or flail mitral valve.
• 18. Presence of prosthetic valve in the aortic or mitral valve.
• 19. Patients with advanced chronic obstructive pulmonary disease (on home oxygen).
• 20. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• 21. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
• 22. Intracardiac thrombus on imaging.
• 23. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).
• 24. Contraindication to anticoagulation.
• 25. End-stage renal disease (requiring dialysis).
• 26. Acute illness, active infection, or sepsis.
• 27. Life expectancy less than 12 months.
• 28. 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.
• 29. Body mass index \>45 kg/m².
• 30. Known ongoing drug or alcohol dependency.
• 31. 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.
• 32. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
• 33. 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.