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The TRAMPOLINE VT Study

NCT05152784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2024-09-23
Completion
2024-09-23
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152784 on ClinicalTrials.gov