Ventricular Tachycardia
Conditions
Keywords
Octaray
Brief summary
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will 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 and Optrell catheters 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. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.
Interventions
DEVICEOctaray catheter
A high density diagnostic catheter used for substrate and activation mapping.
DEVICEStandard of care
VT ablation guided by substrate-mapping alone.
Sponsors
Biosense Webster, Inc.
Barts & The London NHS Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Propensity-matched cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct identification of VT exit site | Intra-procedural | 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%) |
| Completeness of diastolic pathway recording | Intra-procedural | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for ICD therapies at 1 year | 12 months following VT ablation | 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 |
| VT burden | 12 months following VT ablation | 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 |
| Symptoms related to arrhythmia | 12 months following VT ablation | 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 |
| Morphological changes on serial cardiac MRIs | 3 months following VT ablation | Cardiac MRI (CMR) will be performed before and 3 months post ablation. Changes in functional, volumetric and scar-related data will be recorded |
Countries
United Kingdom
Outcome results
None listed