Monomorphic Ventricular TachycardiaRipple-VTNCT02216760
Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.
A study testing Ripple Mapping guided VT ablation and Conventional VT ablation in people with Monomorphic Ventricular Tachycardia and Myocardial Infarction, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Monomorphic Ventricular Tachycardia, Myocardial Infarction, Dilated Cardiomyopathy
- What is being tested?
- Ripple Mapping guided VT ablation and Conventional VT ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to catheter ablation
- Coronary revascularisation required
- Ventricular tachycardia due to transient, reversible causes
- Presence of cardiac thrombus
- Severe cerebrovascular disease
- Active gastrointestinal disease
Show all 16Show fewer
- 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
- Unable to attend follow-up visits or ICD clinics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Determining the Pathophysiological Role of Slow Conduction Channels Identified by Ripple Mapping of the Ventricular Scar.
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.
Read more
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.
Read the detailed description
In patients with a previous heart attack, the scar formed in the left ventricle (bottom chamber of the heart) consists of dead tissue mixed with strands of live tissue which form "conduction channels" (CC's). These Conduction channels can cause dangerous heart rhythms such as Ventricular Tachycardia (VT). This can lead to symptoms such as shortness of breath, dizziness, blackouts, and, in some, sudden death.
Patients at risk of sudden death receive special implanted devices called implantable cardioverter defibrillators (ICD) and can present with recurrent painful and debilitating ICD therapies consisting of internal shocks. Patients experiencing frequent ICD shocks due recurrent VT usually undergo a procedure to burn (ablate) the area of scar within the heart thought to be the source of the VT. This involves catheters (plastic tubes) inserted into the heart via the groin vessels allowing the cardiac electrophysiologists to obtain information about the scar. Scar tissue has low electrical voltage. By measuring the electrical voltage of the tissue in the heart, areas of scar as well as areas of live, healthy tissue can be identified and mapped. By burning (ablation) these abnormal channels of live tissue within scar (conduction channels), this can effectively reduce the episodes of VT a patient experiences, thereby reducing the frequency of shocks they experience and improve their quality of life.
In any one patient, more than 1 conduction channel and hence source of VT can be found. Current mapping technologies are incapable of providing electrophysiologists with the information that is required to locate all these conduction channels. Therefore ablation strategies have shifted from ablating in a single location in the scar, to extensive ablation within the scar in the hope that ALL conduction channels will be burnt. However, this extensive ablation strategy has no globally agreed consensus with several techniques used worldwide.
The disadvantage of this extensive ablation strategy is that the potential regions which can be responsible for VT can be large, requiring extensive ablation and therefore prolonged procedure times in sick patients who are unable to tolerate such lengthy procedures. In its current state, VT ablation by any strategy is technically challenging and time consuming with procedural times as long as 8 hours. In addition, although acute procedural success ranges from 77% to 95%, recurrence rates remain high - up to 50%.
Therefore, identification of ALL conduction channels within scar is a desirable goal for catheter ablation therapy in VT. Ripple Mapping (RM) is a novel mapping program which allows simultaneous display of "voltage" and "activation" data of the underlying ventricular tissue. RM therefore has the potential to display more detailed information of the functional properties of the underlying scar including any interspersed live tissue channels. Investigators at Imperial College have demonstrated the proof of concept of RM and validated the program in a series of abnormal heart rhythms that arise within the upper heart chambers (the atria) where RM was found to have a superior diagnostic yield as well as aiding the operator in reaching a diagnosis in shorter time when compared with conventional mapping systems. The Investigators subsequently performed a retrospective analysis of 21 patients undergoing post infarct VT ablation. All documented locations with concealed entrainment or perfect pace matches to the induced or clinical VT coincided with Ripple Mapping Conduction Channels (RMCC). In patients where ablation lesions overlapped all identified RMCCs, these patients remained free of VT recurrence for >2 year follow up interval.
The Investigators therefore propose to study the hypothesis 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. This will be determined via a prospective randomised study comparing Ripple Mapping guided VT ablation against conventional VT ablation.
- Being tested
- Ripple Mapping guided VT ablation, Conventional VT ablation
- Keywords
- Monomorphic Ventricular Tachycardia, Myocardial infarction, Dilated cardiomyopathy, Catheter ablation, Substrate mapping, Ripple Conduction channels
- Medical subject headings
- Myocardial Infarction, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripple Mapping guided VT ablationDevice
Also called Ripple Mapping Carto 3 V4.2 System
RM will be used to guide identification of conduction channels and hence substrate guided ablation
Conventional VT ablationDevice
Substrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation)
| Study group | Role | What they receive |
|---|---|---|
| Ripple Mapping guided VT ablation | Active comparator | 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. Receives: Device: Ripple Mapping guided VT ablation |
| Conventional VT Ablation | Active comparator | Standard substrate ablation as per local operator preference will be used to guide ablation in the ventricular scar in patients with monomorphic VT. Receives: Device: Conventional VT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post ablation procedure
Secondary outcomes (2)
Total appropriate ICD episodes
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. Appropriate ICD therapy burden (Anti-tachycardia Pacing + shocks) as well VT below the therapy zone will be recorded since the last device download and reset. The total number of episodes will be calculated and recorded for each patient at the end of 2 year follow up interval.
Measured: 24 months post ablation procedure
VT induction post procedure
Immediately following VT ablation, programmed ventricular stimulation will be repeated to assess whether VT is inducible. Patient outcomes will be divided into 3 groups. Group A: VT non-inducible; Group B: Non-clinical VT induced. Group C: No RMCC's identified to guide ablation OR clinical VT remains inducible. The total number of patients in each group will be calculated and reported.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Terminated prior to randomised phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Monomorphic Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prapa Kanagaratnam, MBBChir PhD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216760
- Sponsor's protocol ID
- 14HH1922
- Acronym
- Ripple-VT
- Status last verified
- May 2019
- First submitted
- 7 Aug 2014
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19959125Jamil-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.
PubMed 24118203
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Pathophysiological Role of Slow Conduction Channels Identified by Ripple Mapping of the Ventricular Scar.
- ClinicalTrials.gov ID
- NCT02216760
- Acronym / sponsor ID
- Ripple-VT / 14HH1922
- Keywords
- Monomorphic Ventricular Tachycardia, Myocardial infarction, Dilated cardiomyopathy, Catheter ablation, Substrate mapping, Ripple Conduction channels
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated prior to randomised phase
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In patients with a previous heart attack, the scar formed in the left ventricle (bottom chamber of the heart) consists of dead tissue mixed with strands of live tissue which form "conduction channels" (CC's). These Conduction channels can cause dangerous heart rhythms such as Ventricular Tachycardia (VT). This can lead to symptoms such as shortness of breath, dizziness, blackouts, and, in some, sudden death.
Patients at risk of sudden death receive special implanted devices called implantable cardioverter defibrillators (ICD) and can present with recurrent painful and debilitating ICD therapies consisting of internal shocks. Patients experiencing frequent ICD shocks due recurrent VT usually undergo a procedure to burn (ablate) the area of scar within the heart thought to be the source of the VT. This involves catheters (plastic tubes) inserted into the heart via the groin vessels allowing the cardiac electrophysiologists to obtain information about the scar. Scar tissue has low electrical voltage. By measuring the electrical voltage of the tissue in the heart, areas of scar as well as areas of live, healthy tissue can be identified and mapped. By burning (ablation) these abnormal channels of live tissue within scar (conduction channels), this can effectively reduce the episodes of VT a patient experiences, thereby reducing the frequency of shocks they experience and improve their quality of life.
In any one patient, more than 1 conduction channel and hence source of VT can be found. Current mapping technologies are incapable of providing electrophysiologists with the information that is required to locate all these conduction channels. Therefore ablation strategies have shifted from ablating in a single location in the scar, to extensive ablation within the scar in the hope that ALL conduction channels will be burnt. However, this extensive ablation strategy has no globally agreed consensus with several techniques used worldwide.
The disadvantage of this extensive ablation strategy is that the potential regions which can be responsible for VT can be large, requiring extensive ablation and therefore prolonged procedure times in sick patients who are unable to tolerate such lengthy procedures. In its current state, VT ablation by any strategy is technically challenging and time consuming with procedural times as long as 8 hours. In addition, although acute procedural success ranges from 77% to 95%, recurrence rates remain high - up to 50%.
Therefore, identification of ALL conduction channels within scar is a desirable goal for catheter ablation therapy in VT. Ripple Mapping (RM) is a novel mapping program which allows simultaneous display of "voltage" and "activation" data of the underlying ventricular tissue. RM therefore has the potential to display more detailed information of the functional properties of the underlying scar including any interspersed live tissue channels. Investigators at Imperial College have demonstrated the proof of concept of RM and validated the program in a series of abnormal heart rhythms that arise within the upper heart chambers (the atria) where RM was found to have a superior diagnostic yield as well as aiding the operator in reaching a diagnosis in shorter time when compared with conventional mapping systems. The Investigators subsequently performed a retrospective analysis of 21 patients undergoing post infarct VT ablation. All documented locations with concealed entrainment or perfect pace matches to the induced or clinical VT coincided with Ripple Mapping Conduction Channels (RMCC). In patients where ablation lesions overlapped all identified RMCCs, these patients remained free of VT recurrence for >2 year follow up interval.
The Investigators therefore propose to study the hypothesis 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. This will be determined via a prospective randomised study comparing Ripple Mapping guided VT ablation against conventional VT ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ripple Mapping guided VT ablation | Active comparator | Device: Ripple Mapping guided VT ablationRipple 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 comparator | Device: Conventional VT ablationStandard substrate ablation as per local operator preference will be used to guide ablation in the ventricular scar in patients with monomorphic VT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Contraindication to catheter ablation
- Coronary revascularisation required
- Ventricular tachycardia due to transient, reversible causes
- Presence of cardiac thrombus
- Severe cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripple Mapping guided VT ablationAlso: Ripple Mapping Carto 3 V4.2 SystemRM will be used to guide identification of conduction channels and hence substrate guided ablation | Device | Ripple Mapping guided VT ablation |
| Conventional VT ablationSubstrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation) | Device | Conventional VT Ablation |
Primary outcome
Time to first appropriate ICD therapy
Time frame: 24 months post ablation procedure
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.
2 secondary outcomes
Total appropriate ICD episodes
Time frame: 24 months post ablation procedure
VT induction post procedure
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 19959125Linton 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.
- Background: PubMed 24118203Jamil-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prapa Kanagaratnam, MBBChir PhD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ripple Mapping guided VT ablation and Conventional VT ablation in people with Monomorphic Ventricular Tachycardia and Myocardial Infarction, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first appropriate ICD therapy (time frame: 24 months post ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.