Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia

Inclusion criteria

• Patient has recurrent, symptomatic, monomorphic VT
• Patient has drug refractory or drug intolerant VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
• A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
• Patient has minimum 3 month ICD interrogation history available for evaluation
• Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation
• Patient is at least 18 years old
• Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

Exclusion criteria

• Patients with idiopathic VT
• Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
• Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk.
• Patient with myocardial infarction (MI) or unstable angina within previous 60 days
• Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
• Patient with class IV (NYHA) heart failure
• Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet
• Patient with left ventricular assist device planned or required for the procedure
• Patients with co-morbidities such that they have less than 1 year life expectancy
• Patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days of the ablation procedure
• Patient with thrombocytopenia or other coagulopathy
• Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test)
• Patient with other acute illness or active systemic infection (unrelated to VT or its origin)
• Significant congenital anomaly heart disease or anomaly
• Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
• Patient concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results.