The TRAMPOLINE VT Study

Not Applicable

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: Standard of care; Device: Octaray catheter

• Registration Number: NCT05152784
• Lead Sponsor: Barts & The London NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-10
• Study Start: 2022-11-21
• Primary Completion: 2024-09-23
• Study Completion: 2024-09-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone.
Octaray catheter	Octaray catheter	VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom