The TRAMPOLINE VT Study

NCT05152784 | Completed DMC FDA Device

• 1 other identifier: 293735
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

Octaray

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Requirement for ICD therapies at 1 year

  12 months following VT ablation

• VT burden

  12 months following VT ablation

• Symptoms related to arrhythmia

  12 months following VT ablation

• Morphological changes on serial cardiac MRIs

  3 months following VT ablation

Study Arms (2)

Octaray catheter

EXPERIMENTAL

VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data.

Device: Octaray catheter

Standard of care

ACTIVE COMPARATOR

Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone.

Device: Standard of care

Interventions

Octaray catheter DEVICE

A high density diagnostic catheter used for substrate and activation mapping.

Octaray catheter

Standard of care DEVICE

VT ablation guided by substrate-mapping alone.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

St. Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Propensity-matched cohort study

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 10, 2021
• Study Start: November 21, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)