Terminated prior to randomised phase
Ripple-VT
Determining the Pathophysiological Role of Slow Conduction Channels Identified by Ripple Mapping of the Ventricular Scar.
Sponsor study identifier
interventional
0
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 7, 2014
Actual (reported)August 15, 2014
Actual (reported)August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time to first appropriate ICD therapy
There will be a 1 week post procedural blanking period. Patients will be followed up at month 3, 6, 12, 18, 24 months for ICD device interrogation post blanking interval. The presence of appropriate ICD therapy as seen on the device download will be analysed on each occasion, and the time (days) from enrollment to the study to the ICD episode will be recorded.
24 months post ablation procedure
Total appropriate ICD episodes
24 months post ablation procedure
VT induction post procedure
1 day
Ripple Mapping (Imperial College) software (Biosense Webster) will be used to identify conduction channels within the ventricular scar substrate to guide ablation lesions in patients with monomorphic VT.
Standard substrate ablation as per local operator preference will be used to guide ablation in the ventricular scar in patients with monomorphic VT.
RM will be used to guide identification of conduction channels and hence substrate guided ablation
Substrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation)
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Linton NW, Koa-Wing M, Francis DP, Kojodjojo P, Lim PB, Salukhe TV, Whinnett Z, Davies DW, Peters NS, O'Neill MD, Kanagaratnam P. Cardiac ripple mapping: a novel three-dimensional visualization method for use with electroanatomic mapping of cardiac arrhythmias. Heart Rhythm. 2009 Dec;6(12):1754-62. doi: 10.1016/j.hrthm.2009.08.038. Epub 2009 Sep 3.
Jamil-Copley S, Linton N, Koa-Wing M, Kojodjojo P, Lim PB, Malcolme-Lawes L, Whinnett Z, Wright I, Davies W, Peters N, Francis DP, Kanagaratnam P. Application of ripple mapping with an electroanatomic mapping system for diagnosis of atrial tachycardias. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1361-9. doi: 10.1111/jce.12259. Epub 2013 Oct 10.
Prapa Kanagaratnam, MBBChir PhD
Imperial College Healthcare NHS Trust
0 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2014
First Posted
August 15, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2019
Record last verified: 2019-05
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