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Completed

NCT Number: NCT05152784

The TRAMPOLINE VT Study

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Bartholomew's Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octaray catheter

Device

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

Standard of care

Device

VT ablation guided by substrate-mapping alone.

Primary outcomes

  1. Correct identification of VT exit site

    Time frame: 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%)

  2. Completeness of diastolic pathway recording

    Time frame: 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 outcomes

  1. Requirement for ICD therapies at 1 year

    Time frame: 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

  2. VT burden

    Time frame: 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

  3. Symptoms related to arrhythmia

    Time frame: 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

  4. Morphological changes on serial cardiac MRIs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2021
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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