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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05152784
Other study ID # 293735
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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