Atrial TachycardiaRIPPLE-ATNCT02451995
Effectiveness of Ripple Mapping in Atrial Tachycardia Ablation
A study testing Ripple Mapping guided AT ablation and Local activation Time Mapping AT Ablation in people with Atrial Tachycardia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts and breathlessness. They are caused either by a cluster of abnormal cells within the heart, or an electrical short circuit which rotates rapidly around the heart. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Tachycardia
- What is being tested?
- Ripple Mapping guided AT ablation and Local activation Time Mapping AT Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Patients undergoing clinically indicated ablation for atrial tachycardia using 3D mapping.
Who cannot join
- 1. Patients with typical flutter.
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: A Prospective Multi-centre Study of Effectiveness of Ripple Mapping for Atrial Tachycardia Ablation
Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts and breathlessness. They are caused either by a cluster of abnormal cells within the heart, or an electrical short circuit which rotates rapidly around the heart. Sometimes these can be controlled with tablets, though owing to side effects many patients want something else. Many tachycardia's can be cured by a procedure known as an "ablation". In essence, either the focus of abnormal cells or the narrowest point of the short circuit causing the abnormal heart rhythm (the source) is electrically destroyed (burnt) resulting in restoration of the normal heart beat.
One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two chambers of the heart (the atrium). Interestingly, this problem is frequently seen in patients who have previously undergone an ablation or surgical procedure for a condition called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current strategies to find the "source" during an ablation procedure are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.
Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to study. RM displays electrical information within the heart as a series of bars coming out of the chamber, with each bar representing signals travelling down the heart. By seeing the pattern of electrical information, they believe it will show the pattern of the tachycardia better than conventional techniques. In a previous retrospective study that they conducted, RM found the source of the tachycardia in 80% of the maps, compared to only 50% with the current system. Investigators at Imperial College have identified why they did not get 100% and they believe that, in future, RM will find the source of the tachycardia first time, and every time.
Read the detailed description
Conventional mapping strategies used to find the "source" of "atrial tachycardia" within the heart are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.
In a retrospective study conducted by investigators at Imperial College, Ripple Mapping (RM) found the source of the tachycardia 80% of the time, compared to only 50% with conventional maps (known as local activation time maps). They have since studied the reasons why did not achieve 100%, but could not improve matters with a retrospective data-set. They believe that, in future, Ripple mapping will find the source of the tachycardia first time, and every time. The purpose of this study is to prospectively test whether Ripple Mapping is better at finding the source of the "atrial tachycardia" (AT) than conventional local activation time mapping.
Patients referred for clinically indicated AT ablation by their electro-physiologist will be recruited. For each patient recruited to the study, they will be block randomized into 2 arms: Ripple Mapping guided AT ablation, or Conventional AT guided Ablation (local activation time mapping). Following explanation of the study the patients will be allowed time to decide on whether they would like to participate.
Following completion of the consent procedure the patient will undergo the electrophysiology study as is routine standard practice. This is usually performed by inserting plastic tubes (catheters) into the heart using the vessels in the groin. Once the catheter is in the atrium (top chambers of the heart) the catheter will be moved to different locations in the chamber to gather the electrical information of the tissue. Using "CARTO3v4 ConfiDENSE", a 3-Dimensional map of the geometry of the heart chambers will be constructed.
Patient randomized to RM will proceed as follows: Once sufficient points have been collected, the Ripple Map will be played in order to diagnose the source of the tachycardia. In the context of a clear diagnosis, the operator can proceed to ablation at the defined source from the Ripple map. Termination of the tachycardia with ablation will be used to confirm the diagnosis was correct. A single entrainment is permissible where the diagnosis is unclear.
Patients randomized to conventional local activation time (LAT) mapping will proceed according to standard practice of the operator. When the operator is satisfied adequate number of points have been collected, the operator can proceed to ablation if the diagnosis is clear. A single entrainment is permissible where the diagnosis is unclear. The endpoints measured will include:
- Tachycardia change or termination following first series of ablations with Ripple Mapping vs local activation time mapping.
- The reliance on entrainment.
- Conditions
- Atrial Tachycardia
- Being tested
- Ripple Mapping guided AT ablation, Local activation Time Mapping AT Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripple Mapping guided AT ablationDevice
Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping
Local activation Time Mapping AT AblationDevice
Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of local activation time mapping
| Study group | Role | What they receive |
|---|---|---|
| Ripple Mapping guided AT ablation | Experimental | Ripple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation Receives: Device: Ripple Mapping guided AT ablation |
| Local activation Time Mapping AT Ablation | Active comparator | Standard activation mapping will be used to guide ablation. Receives: Device: Local activation Time Mapping AT Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.
The total number of participants in each arm with either a change of termination of their atrial tachycardia following delivery of the first ablation set post map categorisation.
Measured: Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial 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
- None (open label)
- Enrolment
- 105 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
- NCT02451995
- Sponsor's protocol ID
- 14HH2319
- Acronym
- RIPPLE-AT
- Status last verified
- Jul 2019
- First submitted
- 14 Apr 2015
- Last updated
- 25 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 24118203Luther V, Agarwal S, Chow A, Koa-Wing M, Cortez-Dias N, Carpinteiro L, de Sousa J, Balasubramaniam R, Farwell D, Jamil-Copley S, Srinivasan N, Abbas H, Mason J, Jones N, Katritsis G, Lim PB, Peters NS, Qureshi N, Whinnett Z, Linton NWF, Kanagaratnam P. Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations. Circ Arrhythm Electrophysiol. 2019 Aug;12(8):e007394. doi: 10.1161/CIRCEP.118.007394. Epub 2019 Aug 9.
PubMed 31394921
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre Study of Effectiveness of Ripple Mapping for Atrial Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT02451995
- Acronym / sponsor ID
- RIPPLE-AT / 14HH2319
- Conditions
- Atrial Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Posted 25 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts and breathlessness. They are caused either by a cluster of abnormal cells within the heart, or an electrical short circuit which rotates rapidly around the heart. Sometimes these can be controlled with tablets, though owing to side effects many patients want something else. Many tachycardia's can be cured by a procedure known as an "ablation". In essence, either the focus of abnormal cells or the narrowest point of the short circuit causing the abnormal heart rhythm (the source) is electrically destroyed (burnt) resulting in restoration of the normal heart beat.
One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two chambers of the heart (the atrium). Interestingly, this problem is frequently seen in patients who have previously undergone an ablation or surgical procedure for a condition called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current strategies to find the "source" during an ablation procedure are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.
Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to study. RM displays electrical information within the heart as a series of bars coming out of the chamber, with each bar representing signals travelling down the heart. By seeing the pattern of electrical information, they believe it will show the pattern of the tachycardia better than conventional techniques. In a previous retrospective study that they conducted, RM found the source of the tachycardia in 80% of the maps, compared to only 50% with the current system. Investigators at Imperial College have identified why they did not get 100% and they believe that, in future, RM will find the source of the tachycardia first time, and every time.
Detailed description
Conventional mapping strategies used to find the "source" of "atrial tachycardia" within the heart are technically challenging resulting in long procedure times. Sometimes the wrong source is found resulting in ablation at the incorrect site.
In a retrospective study conducted by investigators at Imperial College, Ripple Mapping (RM) found the source of the tachycardia 80% of the time, compared to only 50% with conventional maps (known as local activation time maps). They have since studied the reasons why did not achieve 100%, but could not improve matters with a retrospective data-set. They believe that, in future, Ripple mapping will find the source of the tachycardia first time, and every time. The purpose of this study is to prospectively test whether Ripple Mapping is better at finding the source of the "atrial tachycardia" (AT) than conventional local activation time mapping.
Patients referred for clinically indicated AT ablation by their electro-physiologist will be recruited. For each patient recruited to the study, they will be block randomized into 2 arms: Ripple Mapping guided AT ablation, or Conventional AT guided Ablation (local activation time mapping). Following explanation of the study the patients will be allowed time to decide on whether they would like to participate.
Following completion of the consent procedure the patient will undergo the electrophysiology study as is routine standard practice. This is usually performed by inserting plastic tubes (catheters) into the heart using the vessels in the groin. Once the catheter is in the atrium (top chambers of the heart) the catheter will be moved to different locations in the chamber to gather the electrical information of the tissue. Using "CARTO3v4 ConfiDENSE", a 3-Dimensional map of the geometry of the heart chambers will be constructed.
Patient randomized to RM will proceed as follows: Once sufficient points have been collected, the Ripple Map will be played in order to diagnose the source of the tachycardia. In the context of a clear diagnosis, the operator can proceed to ablation at the defined source from the Ripple map. Termination of the tachycardia with ablation will be used to confirm the diagnosis was correct. A single entrainment is permissible where the diagnosis is unclear.
Patients randomized to conventional local activation time (LAT) mapping will proceed according to standard practice of the operator. When the operator is satisfied adequate number of points have been collected, the operator can proceed to ablation if the diagnosis is clear. A single entrainment is permissible where the diagnosis is unclear. The endpoints measured will include:
- Tachycardia change or termination following first series of ablations with Ripple Mapping vs local activation time mapping.
- The reliance on entrainment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ripple Mapping guided AT ablation | Experimental | Device: Ripple Mapping guided AT ablationRipple Mapping (Imperial College) software (Biosense Webster) will be used to diagnose the mechanism of AT and guide ablation |
| Local activation Time Mapping AT Ablation | Active comparator | Device: Local activation Time Mapping AT AblationStandard activation mapping will be used to guide ablation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients undergoing clinically indicated ablation for atrial tachycardia using 3D mapping.
Key exclusion criteria (1 listed)
- 1. Patients with typical flutter.
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 AT ablationDiagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping | Device | Ripple Mapping guided AT ablation |
| Local activation Time Mapping AT AblationDiagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of local activation time mapping | Device | Local activation Time Mapping AT Ablation |
Primary outcome
A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.
Time frame: Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.
The total number of participants in each arm with either a change of termination of their atrial tachycardia following delivery of the first ablation set post map categorisation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 31394921Luther V, Agarwal S, Chow A, Koa-Wing M, Cortez-Dias N, Carpinteiro L, de Sousa J, Balasubramaniam R, Farwell D, Jamil-Copley S, Srinivasan N, Abbas H, Mason J, Jones N, Katritsis G, Lim PB, Peters NS, Qureshi N, Whinnett Z, Linton NWF, Kanagaratnam P. Ripple-AT Study: A Multicenter and Randomized Study Comparing 3D Mapping Techniques During Atrial Tachycardia Ablations. Circ Arrhythm Electrophysiol. 2019 Aug;12(8):e007394. doi: 10.1161/CIRCEP.118.007394. Epub 2019 Aug 9.
- Individual participant dataSharing planned: No
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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 AT ablation and Local activation Time Mapping AT Ablation in people with Atrial Tachycardia, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jul 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?
Yes. Results are posted in the registry (first posted 25 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set. (time frame: Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.). 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 NCT02451995, which also lists 3 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 25 Jul 2019.