Real-time Automated Program for IDentification of VT Origin

Study Overview
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Brief Summary
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RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.

Detailed Description
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Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration. During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites. Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.

Official Title
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Real-time Automated Program for IDentification of VT Origin - Pilot Study

Conditions
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Ventricular Tachycardia, Ischemic Heart Disease

Intervention / Treatment
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* Other: RAPID-VT Software guided ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug: A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD Exclusion Criteria: Patients will be excluded from the trial if they: Are unable or unwilling to provide informed consent. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization. Are antiarrhythmic drug-naïve. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves. Have had a prior catheter ablation procedure for VT. Are in renal failure (Creatinine clearance <15 mL/min) Have NYHA Functional class IV heart failure or CCS Functional class IV angina. Have had recent ST elevation myocardial infarction (< 1 month). Are pregnant or have a systemic illness likely to limit survival to <1 year.

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: RAPID-VT Software guided ablation<br>The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation | Other: RAPID-VT Software guided ablation<br>* Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inducibility of VT | Lack of any inducible VT at the end of the ablation procedure | At end of ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure efficacy measure: VT(s) ablated | Number of VTs identified and targeted with ablation | At end of procedure | 
| Procedure efficacy measure: Procedure duration | Duration of procedure in minutes | At end of procedure | 
| Procedure efficacy measure: VT recurrence | Time to recurrence of VT in months | During follow up period of 6 months | 
| Procedure safety measure: Acute complications | Incidence of any procedure-related complications | At end of procedure and at 30 days of follow up | 
| Procedure safety measure: Clinical heart failure worsening | Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT | At end of procedure, at 30 days and 6 months of follow up | 
| Procedure safety measure: Mortality and hospitalization for cardiac causes | Death and/or cardiac hospitalization | At 30 days and 6 months of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, ECG imaging