Ventricular TachycardiaNCT05500365
In Silico Pace Mapping To Optimise Ventricular Tachycardia Ablation
An observational study of Ventricular Tachycardia, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
People who suffer from incessant cardiac arrhythmias receive a small electrical device implanted into their chest that automatically senses when the heart beats arrhythmically and applies electrical pulse to re-establish normal activity. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Catheter ablation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Oct 2025
- Phase
- Observational
- 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 99 years
- All sexes
- Adult, Older adult
Study population: Ischemic cardiomyopathy suffering from refractory ventricular tachycardia
Who may be able to join
- Age 18 to 99 years
- Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
- Ventricular tachycardia secondary to ischemic heart disease clinically indicated for catheter ablation therapy
- Cardiac implanted electronic device in situ
Who cannot join
- Standard contra-indications to VT ablation
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Contra-indication to contrast agent for Cardiac MRI scan
- Implanted device that is not MRI-conditional
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Clinical Validation of an In Silico Pace Mapping Approach Utilising Implanted Device Electrograms to Accurately Guide Ventricular Tachycardia Ablation
People who suffer from incessant cardiac arrhythmias receive a small electrical device implanted into their chest that automatically senses when the heart beats arrhythmically and applies electrical pulse to re-establish normal activity. However, if problems persist, people can have an operation called catheter ablation therapy, which involves 'burning' small areas of the heart tissue in order to permanently disrupt the problematic electrical pathways driving these arrhythmias.
However, procedure times and complication rates are high, whist success rates are punitively low (~50% success), largely due to the significant challenge clinicians face in identifying the ideal 'target' to ablate within the patient's heart. In this project, the investigators aim to develop, and clinically validate, an in silico tool that reconstructs a personalised computational model of a patient's heart using advanced MRI data, upon which a virtual 'mapping' procedure is then performed in order to identify (in the model) the optimal ablation target. This pre-procedural planning tool utilises stored information about the patient's specific arrhythmia from their implanted device, ensuring optimal targets are selected. The approach aims to reduce procedure times whilst increasing their safety, and ensure significantly increased long-term effectiveness of these invasive ablation procedures, increasing survival rates and quality-of-life.
This study is concerned with the clinical arm of the study, specifically, in the collection of data from patients in order to (retrospectively) validate the computational model. The model itself will not be applied or used to treat these patients.
Read the detailed description
Catheter ablation of ventricular tachycardia (VT) most frequently requires the identification of exit sites of slow-conducting diastolic isthmuses associated with infarcted tissue which are critical to sustain the reentrant arrhythmia. Pace mapping is a technique that identifies exit sites by matching the recorded 12-lead electrocardiogram (ECG) QRS of catheter-paced beats at different myocardial locations with the QRS of the clinical VT. When a high correlation between QRS morphologies is found, it is believed that the paced-beat lies at the VT exit site, helping guide the ablation. Procedures thus involve methodologically moving the catheter to multiple (accessible) locations to produce a pace map. Unfortunately the procedure is inherently limited due to the following reasons:
- Surface maps - Most often, pacing sites are limited to the endocardium (where catheter access is easiest). Consequently, identification of VTs with an intramural or epicardial substrate can be challenging, with mis-leading and/or difficult to interpret pace maps being obtained. ii) Low Resolution - Due to time-pressures and practical difficulties in catheter manipulation, pace map sites are often sparsely located (typically 40-60 separate sites). In complex structural VTs, with multiple possible anatomical circuits through the scar, it is often challenging to accurately identify from the map the relevant isthmus exit site responsible for the presenting clinical VT. iii) VT Induction - Pace mapping usually necessitates VT induction during the procedure, which is time-consuming and carries inherent risk (~80% of induced VTs in ischemic heart disease (IHD) are either non-sustained or not haemodynamically tolerated), but induction of the exact clinical VT itself is often challenging.
A non-invasive, pre-procedural approach that is capable of generating accurate, high-resolution 3-dimensional personalised pace maps that correlate with the presenting clinical VT without the need for VT induction would thus revolutionise VT ablation planning, guidance, safety and efficacy.
Two recent studies have demonstrated the utility of performing a pace map based on comparison to stored implanted cardioverter defibrillator (ICD) electrograms (EGMs) of the clinical VT. The first study initially demonstrated that stored ICD EGMs allow differentiation of the clinical VT from other VTs, and their subsequent use in pace mapping may be useful for identifying the VT exit site. More recently, it has been prospectively shown that pace mapping of non-inducible clinical VTs based on ICD EGMs is feasible and resulted in higher freedom from recurrent VT, compared to targeting only inducible VTs.
The investigators have recently published a pipeline for creating a patient-specific image-based whole torso-cardiac model to perform virtual ('in silico') pace mapping. The approach creates a high-resolution 3D pace map that successfully identifies the exit site of an induced (simulated) VT within the same model, using both simulated 12-lead ECG and ICD EGM data derived from the simulated VT episode. Here, it was demonstrated: 1) the importance of creating a dense, fully transmural (3D) pace map to allow differentiation of epicardial vs endocardial substrates; 2) that accuracy of exit site identification could be enhanced by considering multiple EGM sensing vectors, e.g. from multipolar cardiac resynchronisation devices (CRT-D) with additional epicardial electrodes. Developed on simulated data, this workflow now requires full validation with clinical data from ablation patients, as proposed here, and refinement of methodological algorithms.
- Conditions
- Ventricular Tachycardia
- Being tested
- Catheter ablation therapy
- Keywords
- Catheter Ablation, Pace Mapping
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation therapyProcedure or surgery
Pace mapping procedure performed during catheter ablation therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of in silico derived pace map
The primary outcome measure will be the geometrical distance between the exit site (site of highest correlation) identified from the in silico pace map (created from the collected patient data) and the actual pace map derived from the patient.
Measured: At the time of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Oct 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Aldo Rinaldi, MD, Principal investigator, St Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500365
- Sponsor's protocol ID
- v1.0
- Status last verified
- Aug 2022
- First submitted
- 4 Apr 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
PubMed 20828650Yokokawa M, Kim HM, Sharaf Dabbagh G, Siontis KC, Lathkar-Pradhan S, Jongnarangsin K, Latchamsetty R, Morady F, Bogun F. Targeting Noninducible Clinical Ventricular Tachycardias in Patients With Prior Myocardial Infarctions Based on Stored Electrograms. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e006978. doi: 10.1161/CIRCEP.118.006978. Epub 2019 Jun 20.
PubMed 31216885Monaci S, Strocchi M, Rodero C, Gillette K, Whitaker J, Rajani R, Rinaldi CA, O'Neill M, Plank G, King A, Bishop MJ. In-silico pace-mapping using a detailed whole torso model and implanted electronic device electrograms for more efficient ablation planning. Comput Biol Med. 2020 Oct;125:104005. doi: 10.1016/j.compbiomed.2020.104005. Epub 2020 Sep 17.
PubMed 32971325
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of an In Silico Pace Mapping Approach Utilising Implanted Device Electrograms to Accurately Guide Ventricular Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT05500365
- Acronym / sponsor ID
- v1.0
- Conditions
- Ventricular Tachycardia
- Keywords
- Catheter Ablation, Pace Mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Aug 2022 (actual)
- 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.
People who suffer from incessant cardiac arrhythmias receive a small electrical device implanted into their chest that automatically senses when the heart beats arrhythmically and applies electrical pulse to re-establish normal activity. However, if problems persist, people can have an operation called catheter ablation therapy, which involves 'burning' small areas of the heart tissue in order to permanently disrupt the problematic electrical pathways driving these arrhythmias.
However, procedure times and complication rates are high, whist success rates are punitively low (~50% success), largely due to the significant challenge clinicians face in identifying the ideal 'target' to ablate within the patient's heart. In this project, the investigators aim to develop, and clinically validate, an in silico tool that reconstructs a personalised computational model of a patient's heart using advanced MRI data, upon which a virtual 'mapping' procedure is then performed in order to identify (in the model) the optimal ablation target. This pre-procedural planning tool utilises stored information about the patient's specific arrhythmia from their implanted device, ensuring optimal targets are selected. The approach aims to reduce procedure times whilst increasing their safety, and ensure significantly increased long-term effectiveness of these invasive ablation procedures, increasing survival rates and quality-of-life.
This study is concerned with the clinical arm of the study, specifically, in the collection of data from patients in order to (retrospectively) validate the computational model. The model itself will not be applied or used to treat these patients.
Detailed description
Catheter ablation of ventricular tachycardia (VT) most frequently requires the identification of exit sites of slow-conducting diastolic isthmuses associated with infarcted tissue which are critical to sustain the reentrant arrhythmia. Pace mapping is a technique that identifies exit sites by matching the recorded 12-lead electrocardiogram (ECG) QRS of catheter-paced beats at different myocardial locations with the QRS of the clinical VT. When a high correlation between QRS morphologies is found, it is believed that the paced-beat lies at the VT exit site, helping guide the ablation. Procedures thus involve methodologically moving the catheter to multiple (accessible) locations to produce a pace map. Unfortunately the procedure is inherently limited due to the following reasons:
- Surface maps - Most often, pacing sites are limited to the endocardium (where catheter access is easiest). Consequently, identification of VTs with an intramural or epicardial substrate can be challenging, with mis-leading and/or difficult to interpret pace maps being obtained. ii) Low Resolution - Due to time-pressures and practical difficulties in catheter manipulation, pace map sites are often sparsely located (typically 40-60 separate sites). In complex structural VTs, with multiple possible anatomical circuits through the scar, it is often challenging to accurately identify from the map the relevant isthmus exit site responsible for the presenting clinical VT. iii) VT Induction - Pace mapping usually necessitates VT induction during the procedure, which is time-consuming and carries inherent risk (~80% of induced VTs in ischemic heart disease (IHD) are either non-sustained or not haemodynamically tolerated), but induction of the exact clinical VT itself is often challenging.
A non-invasive, pre-procedural approach that is capable of generating accurate, high-resolution 3-dimensional personalised pace maps that correlate with the presenting clinical VT without the need for VT induction would thus revolutionise VT ablation planning, guidance, safety and efficacy.
Two recent studies have demonstrated the utility of performing a pace map based on comparison to stored implanted cardioverter defibrillator (ICD) electrograms (EGMs) of the clinical VT. The first study initially demonstrated that stored ICD EGMs allow differentiation of the clinical VT from other VTs, and their subsequent use in pace mapping may be useful for identifying the VT exit site. More recently, it has been prospectively shown that pace mapping of non-inducible clinical VTs based on ICD EGMs is feasible and resulted in higher freedom from recurrent VT, compared to targeting only inducible VTs.
The investigators have recently published a pipeline for creating a patient-specific image-based whole torso-cardiac model to perform virtual ('in silico') pace mapping. The approach creates a high-resolution 3D pace map that successfully identifies the exit site of an induced (simulated) VT within the same model, using both simulated 12-lead ECG and ICD EGM data derived from the simulated VT episode. Here, it was demonstrated: 1) the importance of creating a dense, fully transmural (3D) pace map to allow differentiation of epicardial vs endocardial substrates; 2) that accuracy of exit site identification could be enhanced by considering multiple EGM sensing vectors, e.g. from multipolar cardiac resynchronisation devices (CRT-D) with additional epicardial electrodes. Developed on simulated data, this workflow now requires full validation with clinical data from ablation patients, as proposed here, and refinement of methodological algorithms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ischemic cardiomyopathy suffering from refractory ventricular tachycardia
Key inclusion criteria (4 listed)
- Age 18 to 99 years
- Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
- Ventricular tachycardia secondary to ischemic heart disease clinically indicated for catheter ablation therapy
- Cardiac implanted electronic device in situ
Key exclusion criteria (4 listed)
- Standard contra-indications to VT ablation
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Contra-indication to contrast agent for Cardiac MRI scan
- Implanted device that is not MRI-conditional
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 |
|---|---|---|
| Catheter ablation therapyPace mapping procedure performed during catheter ablation therapy | Procedure or surgery | – |
Primary outcome
Performance of in silico derived pace map
Time frame: At the time of the procedure.
The primary outcome measure will be the geometrical distance between the exit site (site of highest correlation) identified from the in silico pace map (created from the collected patient data) and the actual pace map derived from the patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Background: PubMed 20828650Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
- Background: PubMed 31216885Yokokawa M, Kim HM, Sharaf Dabbagh G, Siontis KC, Lathkar-Pradhan S, Jongnarangsin K, Latchamsetty R, Morady F, Bogun F. Targeting Noninducible Clinical Ventricular Tachycardias in Patients With Prior Myocardial Infarctions Based on Stored Electrograms. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e006978. doi: 10.1161/CIRCEP.118.006978. Epub 2019 Jun 20.
- Results publication: PubMed 32971325Monaci S, Strocchi M, Rodero C, Gillette K, Whitaker J, Rajani R, Rinaldi CA, O'Neill M, Plank G, King A, Bishop MJ. In-silico pace-mapping using a detailed whole torso model and implanted electronic device electrograms for more efficient ablation planning. Comput Biol Med. 2020 Oct;125:104005. doi: 10.1016/j.compbiomed.2020.104005. Epub 2020 Sep 17.
- Individual participant dataSharing planned: Undecided
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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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.
Aldo Rinaldi, MD principal investigator
St Thomas' Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Guy's and St Thomas' NHS Foundation Trust.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Bishop, DPhil (+44 20 7188 7188 ext. 53219, martin.bishop@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of in silico derived pace map (time frame: At the time of the 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 NCT05500365, 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 13 Mar 2023.