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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octaray catheter | Experimental | VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data. |
|
| Standard of care | Active Comparator | Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octaray catheter | Device | A high density diagnostic catheter used for substrate and activation mapping. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bartholomew's Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Propensity-matched cohort study
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| Standard of care | Device | VT ablation guided by substrate-mapping alone. |
|
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 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |