Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter
 and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
Inclusion Criteria

 1. Patient has recurrent, symptomatic, monomorphic VT

 2. 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

 3. A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.

 4. Patient has minimum 3 month ICD interrogation history available for evaluation

 5. Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline
 evaluation

 6. Patient is at least 18 years old

 7. Patient has signed the informed consent, and is willing and able to participate in all
 study procedures and follow up requirements

 Exclusion Criteria

 1. Patients with idiopathic VT

 2. Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall
 origin findings.

 3. 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.

 4. Patient with myocardial infarction (MI) or unstable angina within previous 60 days

 5. Patient with cardiac surgery or percutaneous coronary intervention (PCI) within
 previous 60 days

 6. Patient with class IV (NYHA) heart failure

 7. Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet

 8. Patient with left ventricular assist device planned or required for the procedure

 9. Patients with co-morbidities such that they have less than 1 year life expectancy

 10. 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

 11. Patient with thrombocytopenia or other coagulopathy

 12. Women who are or may potentially be pregnant. (must be post-menopausal or have a
 negative pregnancy test)

 13. Patient with other acute illness or active systemic infection (unrelated to VT or its
 origin)

 14. Significant congenital anomaly heart disease or anomaly

 15. Allergy or contraindications to the medications/agents used during a standard
 ablation/EP intervention.

 16. Patient concurrently enrolled in any other investigational drug or device study that
 the investigator deems would interfere with study results.