NCT05152784

The TRAMPOLINE VT Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Octaray catheter	A high density diagnostic catheter used for substrate and activation mapping.
DEVICE	Standard of care	VT ablation guided by substrate-mapping alone.

Timeline

• Start date: 2022-11-21
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2021-12-10
• Last updated: 2025-03-25

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study