Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.
NCT02216760 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-05-16
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
- Monomorphic Ventricular Tachycardia
- Myocardial Infarction
- Dilated Cardiomyopathy
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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