The TRAMPOLINE VT Study

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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Octaray catheter; Device: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • St. Bartholomew's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Octaray
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 293735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes