Study Stopped
Terminated prior to randomised phase
Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.
Ripple-VT
Determining the Pathophysiological Role of Slow Conduction Channels Identified by Ripple Mapping of the Ventricular Scar.
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 16, 2019
May 1, 2019
4 years
August 7, 2014
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Total appropriate ICD episodes
24 months post ablation procedure
VT induction post procedure
1 day
Study Arms (2)
Ripple Mapping guided VT ablation
ACTIVE COMPARATORRipple 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.
Conventional VT Ablation
ACTIVE COMPARATORStandard substrate ablation as per local operator preference will be used to guide ablation in the ventricular scar in patients with monomorphic VT.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Evidence of VT (shock/ anti tachycardia pacing/ detection) on ICD (single, dual or bi-ventricular) interrogation or 12 lead ECG.
- Presumed scar related VT post myocardial infraction infarct/ dilated cardiomyopathy.
- Age range 18-85yrs.
- ICD implantation for primary or secondary prophylaxis, or device implantation pre-discharge from hospital post ablation procedure.
- Signed informed consent
You may not qualify if:
- Contraindication to catheter ablation
- Coronary revascularisation required
- Ventricular tachycardia due to transient, reversible causes
- Presence of cardiac thrombus
- Severe cerebrovascular disease
- Active gastrointestinal disease
- Renal failure with creatinine \>200 μmol/L or on dialysis
- Active fever or infection
- Life expectancy shorter than the trial
- Allergy to contrast
- Intractable heart failure (NYHA Class IV)
- Bleeding or clotting disorders or inability to receive heparin
- Pregnancy
- Must not have previous (4 weeks prior to screening) or current participation in another clinical trial with an investigational drug or investigational device
- Unable to give informed consent
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Related Publications (2)
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.
PMID: 19959125BACKGROUNDJamil-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.
PMID: 24118203BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prapa Kanagaratnam, MBBChir PhD
Imperial College Healthcare NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 15, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
May 16, 2019
Record last verified: 2019-05