Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

Study Overview
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Brief Summary
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Vistag SurPoint is a proprietary module that generates a numerical tag index which can be used as multiparametric lesion quality marker to guide ablation in the clinical setting for ablation of atrial arrhythmias. SurPoint tag index has studied to guide ablation of ventricular arrhythmias, such as premature ventricular complexes, but its effectiveness and safety for ablation of Ventricular Tachycardia in patient with Ischemic and Non-Ischemic Cardiomyopathies is not well established. In this single center prospective observation registry, a ventricular ablation strategy utilizing radiofrequency delivery duration cut off determined by a maximum Surpoint index value of 550 will be compared to conventional operator determined duration of radiofrequency delivery based on combination of time (i.e. 30, 60, 90, and 120 seconds), magnitude of impedance drop, attenuation of abnormal electrograms, and achieving non-capture with high-output pacing after ablation. The Surpoint Tag Index Ablation group will be matched with a control group of patients undergoing VT ablation using the conventional time-based radiofrequency strategy and the patients in this group will be selected using propensity matching based on relevant baseline patient and clinical characteristic variables. Primary outcomes of interest: Recurrence of sustained ventricular tachycardia or Internal Cardiac Defibrillator Therapy. Secondary outcomes of interest: Hospitalization for ventricular tachycardia, repeat ablation procedures, all-cause mortality, acute procedural complications, rate of steam pops during ablation procedures Follow up: Up to 24 months after ablation procedure. Follow up will be obtained by office visits and device interrogation reports.

Official Title
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Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia in Patients With Ischemic and Non-Ischemic Cardiomyopathy

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Structural Heart Disease: Ischemic or Non-Ischemic Cardiomyopathy Sustained Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation Exclusion Criteria: If clinical ventricular arrhythmia is predominantly PVCs, polymorphic ventricular tachycardia, or ventricular fibrillation Myocardial infarction or Cardiac Surgery within 6 months Severe mitral regurgitation Stroke or TIA within 6 months Prior Ventricular Tachycardia Ablation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surpoint Index Guided Ablation Group<br>Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550 | Device: Radiofrequency Ablation<br>* Radiofrequency Ablation using irrigated ablation catheter<br>|
| Conventional Ablation Group<br>Operator determined ablation duration regardless of Surpoint Index Value | Device: Radiofrequency Ablation<br>* Radiofrequency Ablation using irrigated ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Event of Sustained Ventricular Tachycardia or ICD therapy | Composite outcome of sustained ventricular tachycardia (episode lasting > 30 seconds detected by ICD) or ventricular tachycardia episode treated successfully by ICD therapy (Including ventricular tachycardia episodes terminated by ATP or ICD shock in < 30 seconds based programmed detection/treatment ICD settings) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for Ventricular Tachycardia | Outcome of hospitalization for primary admission diagnosis of ventricular tachycardia with or without ICD treatment | 2 yearr | 
| All-Cause Mortality | Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause | 2 years | 
| Redo Ventricular Tachycardia Ablation Procedure | Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure | 2 years | 
| Procedural Complications | Outcome of rate of complications with 7 days of ventricular tachycardia ablation procedure including but not limited to bleeding, death, pericardial effusion, cardiac tamponade, stroke, arterial thromboemblism, steam pops, thrombus formation, cardiogenic shock, phrenic nerve paralysis, congestive heart failure) | 7 days |