The TRAMPOLINE VT Study

Study Overview
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Brief Summary
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This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray catheter and the CARTO3 electro-anatomical mapping system. Procedures will integrate data from cardiac MRI and voltage mapping to identify sites of interest for focussed activation mapping; the investigators hypothesise that the examination of these data will identify critical target sites for ablation. Intra-procedural diagnostic performance of the Octaray will be assessed as the primary outcome, and will be compared with the standard of care. Secondary, clinical outcomes - primarily the need for ICD therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone.

Official Title
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Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Octaray catheter
* Device: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD in situ Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs Ischaemic or non-ischaemic heart disease Exclusion Criteria: Valvular heart disease precluding LV access Cardiotomy within previous 3 months Acute coronary syndrome within 6 weeks Dialysis patients Coagulopathy/Thrombocytopaenia Pregnancy/breastfeeding women CMR contraindicated Prognosis <12 months Unable to provide informed consent

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Propensity-matched cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octaray catheter<br>VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data. | Device: Octaray catheter<br>* A high density diagnostic catheter used for substrate and activation mapping.<br>|
| Active Comparator: Standard of care<br>Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone. | Device: Standard of care<br>* VT ablation guided by substrate-mapping alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct identification of VT exit site | The site of VT origin suggested by activation mapping will be confirmed by either: i) Termination with ablation at this site ii) Entrainment of the tachycardia at this site (concealed fusion with PPI-TCL <30ms and equivalent stimulus-QRS interval to EGM-QRS (30-70% TCL) interval) iii) Pace-mapping (average correlation coefficient >90%) | Intra-procedural | 
| Completeness of diastolic pathway recording | The VT diastolic interval will be divided into temporal segments: i) First third: VT entrance ii) Middle third: VT isthmus iii) Final third: VT exit Completeness of diastolic pathway recording will be assessed according to the number of segments in which electrical activity is recorded | Intra-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement for ICD therapies at 1 year | ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the requirement for appropriate anti-tachycardia pacing (ATP) or defibrillation recorded | 12 months following VT ablation | 
| VT burden | ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the number and duration of recorded VT episodes noted | 12 months following VT ablation | 
| Symptoms related to arrhythmia | The Arrhythmia-specific questionnaire in Tachycardia and Arrhythmia (ASTA) will be completed both before and 12 months following ablation to assess for quantitative change in arrhythmia-related symptomatology | 12 months following VT ablation | 
| Morphological changes on serial cardiac MRIs | Cardiac MRI (CMR) will be performed before and 3 months post ablation. Changes in functional, volumetric and scar-related data will be recorded | 3 months following VT ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Octaray