The TRAMPOLINE VT Study

Barts & The London NHS Trust

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Device: Octaray catheter; Device: Standard of care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05152784

293735

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Octaray catheter

Experimental group

Description:

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

Treatment:

Device: Octaray catheter

Standard of care

Active Comparator group

Description:

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

Treatment:

Device: Standard of care