The TRAMPOLINE VT Study

NCT ID: NCT05152784

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2024-09-23

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octaray catheter

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

Group Type: EXPERIMENTAL

Octaray catheter

Intervention Type: DEVICE

A high density diagnostic catheter used for substrate and activation mapping.

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DEVICE

VT ablation guided by substrate-mapping alone.

Interventions

Octaray catheter

A high density diagnostic catheter used for substrate and activation mapping.

Intervention Type: DEVICE

Standard of care

VT ablation guided by substrate-mapping alone.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Bartholomew's Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

293735

Identifier Type: -

Identifier Source: org_study_id