Tests a heart catheter device for ventricular tachycardia in adults

Who can take part

• 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

Who cannot take part

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