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

Study Overview
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Brief Summary
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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)

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

Conditions
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Tachycardia, Ventricular

Intervention / Treatment
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* Device: Saline-Enhanced Radiofrequency Catheter and Ablation System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SERF Catheter Ablation<br>Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter | Device: Saline-Enhanced Radiofrequency Catheter and Ablation System<br>* Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter<br>* Other names: SERF Ablation System and Durablate™ Ablation Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events that are potentially device-related |  | Within 30 days of ablation | 
| Major Adverse Cardiac Events | MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure). | Within 2 days after ablation procedure | 
| Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels |  | At completion of ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraprocedural non-inducibility and/or scar homogenization of target VT |  | At completion of ablation procedure | 
| Elimination of the target VT and/or reduction in number of VT episodes |  | Within first 6 months of ablation procedure |