Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)
The primary objective is to demonstrate safety and feasibility of the Thermedical Ablation
 System and Durablate needle catheter in subjects with recurrent, monomorphic ventricular
 tachycardia (VT) who have failed conventional treatment.
The purpose of this study is to gather information on the safety and effectiveness of a new
 ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This
 catheter is being studied to treat ventricular tachycardia (VT) in patients who have already
 been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an
 ablation procedure to treat their VT but continue to experience VT despite these treatments.
 A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT
 and applying energy with the tip of an ablation catheter to the area to create a scar or
 destroy the tissue that causes the VT. The SERF catheter being used in this study uses a
 needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart
 tissue that is causing the VT than a standard ablation catheter.
Inclusion Criteria:

 1. Subject has sustained, monomorphic VT

 2. Subject has recurrent, symptomatic VT

 3. Subject has drug refractory or drug intolerant sustained 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

 4. ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that
 is suspected to be the same VT as initially targeted in a prior ablation

 5. Subject has minimum 3-month ICD interrogation history available for evaluation

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

 7. Subject is at least 18 years old

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

 Exclusion Criteria:

 1. Subjects with VT of idiopathic origin

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

 3. Subjects with VTs of septal origin require special care to minimize the risk of heart
 block, particularly within 2 cm of the AV node/proximal conduction system; Subjects
 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. Subject with myocardial infarction (MI) or unstable angina within previous 60 days

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

 6. Subject with class IV (NYHA) heart failure

 7. Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve

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

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

 10. Subject with significant intracardiac and/or laminated thrombus evident by
 transesophageal echo (TEE) or transthoracic echo (TTE) (with contrast) prior to
 ablation procedure

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

 14. Significant congenital heart disease or cardiac anomaly

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

 16. Subject concurrently enrolled in any other investigational drug or device study