The TRAMPOLINE VT Study

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152784
• Other study ID #: 293735
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: October 3, 2025

Study information

• Verified date: March 2024
• Source: Barts & The London NHS Trust
• Contact: Pier D Lambiase, MBBS
• Phone: 02073 777000
• Email: p.lambiase[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 3, 2025
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Octaray catheter
A high density diagnostic catheter used for substrate and activation mapping.
• Standard of care
VT ablation guided by substrate-mapping alone.

Locations

Country	Name	City	State
United Kingdom	St. Bartholomew's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Biosense Webster, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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