VT Ablation in the iCMR

Study Overview
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Brief Summary
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The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Official Title
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Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Vision-MR Ablation Catheter 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months Diagnosis of Ischemic Cardiomyopathy AAD therapy refractory, contraindicated, not tolerated, or not desired 18 years or older Exclusion Criteria: Implanted with non-MR compatible medical devices or contraindicated for an MRI Presence of intracardiac thrombus (verified via CT/MRI/echocardiogram within 48 hours of procedure - or at start of procedure) Thrombocytopenia or coagulopathy Mechanical mitral and/or aortic valve precluding access to the left ventricle Severe aortic stenosis Myocardial infarction requiring stent implantation within 90 days of procedure Previous cardiac surgery within 60 days of procedures Class IV Heart Failure Ejection Fraction (EF) < 25% Patients with a glomerular filtration rate (GFR) < 30 Women who are pregnant Life expectancy < 12 months Enrollment in another study without sponsor approval

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: Non-Randomized<br>All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0 | Device: Vision-MR Ablation Catheter 2.0<br>* Catheter ablation of ventricular tachycardia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | Acute success defined as absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the investigational device. | 30 minutes post procedure | 
| Primary Safety Endpoint | Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoint | Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure. | 6 months |