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

Prior treatment

• Incessant VT necessitating hemodynamic support prior to the ablation procedure.
• NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
• 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.
• Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
• Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
• Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
• Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
• Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
• Known ongoing drug or alcohol dependency.
• 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.

Other illness

• VTs due to any of the following:
  • Idiopathic VT
  • Automaticity or triggered activity
  • Lamin or titin genetic mutation
  • Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
• Unstable angina.
• Active myocardial ischemia.
• NYHA Class IV heart failure.
• Decompensated heart failure.
• End-stage renal disease (requiring dialysis).
• Acute illness, active infection, or sepsis.
• 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.

Lab values

• Left ventricular ejection fraction (LVEF) \<15%.
• Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).

Other

• Unstable polymorphic VT or ventricular fibrillation (VF).
• VT or VF thought to be from channelopathies.
• Sarcoidosis.
• Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
• Ventricular assist device (VAD) implanted, planned or required for the procedure.
• Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
• Presence of prosthetic valve in the aortic or mitral valve.
• Patients with advanced COPD (on home oxygen).
• Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
• Contraindication to anticoagulation.
• Life expectancy less than 12 months.
• 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.
• Body mass index \>45 kg/m2.
• Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).

• Any of the following:
  • Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
  • Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
• At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
• Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.
• Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.
• Age 18 through 85 years old.
• Willing and able to provide informed consent.
• Willing and able to comply with all pre-, post-, and follow-up testing requirements.