Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.

NCT02216760 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-16

No results posted yet for this study

Summary

The heart beat is controlled by electrical signals. Following a heart attack, part of the heart muscle dies and is later replaced by scar tissue. Within this area of scar, there often remain "channels" of surviving tissue still able to transmit electrical signals. However, it is well established that these "conduction channels" (CC) can form a short circuit around the scar, leading to electrical disturbances (arrhythmias) that are potentially life threatening. The commonest of these is ventricular tachycardia (VT), and is estimated to cause 300,000 deaths per year.

One recognised treatment option of VT involves burning (ablation) these "conduction channels" (CC) within the scar. However, at present, the procedure is long and is far off 100% effective. Consequently, current best practice does not rely on treating the VT, but rather preventing it from causing sudden death - this is achieved with an Implantable Cardioverter Defibrillator (ICD), a device which can recognise when a patient is in VT and deliver an internal shock to restore the normal electrical conduction. Patients with defibrillators subsequently are subject to recurrent painful and debilitating shocks which, although lifesaving, significantly reduce their quality of life. The limitation with ablation at present is due to the difficulty in visualising these CC's.

Investigators at Imperial College have created a novel electrogram visualisation program, Ripple Mapping (RM), which they have already found to be superior to currently used programmes in cases of arrhythmias in the upper chambers of the heart (the atria). During a retrospective study in patients with scar related VT following a heart attack, when ablation was delivered in areas associated with identified Ripple Mapping Conduction Channels, these patients remained free of VT recurrence for \>2 year follow up interval.

The study hypothesis is that Ripple Mapping can identify all conduction channels within scar tissue critical to the VT circuit, ablation of which will lead to long-term freedom from VT and ICD therapies. The investigators now aim to perform a prospective randomised study comparing Ripple Mapping guided VT ablation against conventional VT ablation.

Conditions

Interventions

DEVICE

Ripple Mapping guided VT ablation

RM will be used to guide identification of conduction channels and hence substrate guided ablation

DEVICE

Conventional VT ablation

Substrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation)

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Prapa Kanagaratnam, MBBChir PhD · Imperial College Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02216760 on ClinicalTrials.gov