Ventricular TachycardiaNCT04632394
Multimodality Assessment of Ventricular Scar Arrhythmogenicity.
An observational study of Ventricular Tachycardia, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
We aim to improve our understanding of a life-threatening heart rhythm disorder known as ventricular tachycardia (VT). This is a disorder which originates from the lower chamber of the heart and frequently is associated with heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Generation of computational model from cardiac MRI. and VT ablation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 2 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The study setting is a large tertiary centre hospital in London, St George's University Hospital which serves a population of around 1.3 million. It also receives referrals from district general hospitals in the surrounding area. Referrals are made to a specialist arrhythmia clinic from which suitable patients can be identified. The majority of recruited patients are expected to be outpatients who are symptomatic from VT despite optimal medical therapy. This will allow sufficient time to perform the cardiac MRI and to generate the computational model. In some scenarios, emergency admissions with symptomatic VT may be included if they are suitable for inpatient VT ablation and there is sufficient time for the MRI and computation analysis to take place prior to the VT ablation.
Who may be able to join
- Adult inpatients admitted to St George's Hospital London with sustained ventricular tachycardia or outpatients identified from the arrhythmia clinic with significant monomorphic ventricular tachycardia noted on cardiac monitoring who:
- Have sustained, monomorphic scar-dependent ventricular tachycardia
- Are symptomatic
- Failed, unable or unwilling to tolerate anti-arrhythmic medications
- Able to have a cardiac MRI
- Have a life expectancy > 1 year
- At least 40 days following a myocardial infarction
Who cannot join
- Patients under the age of 18
- Patients who are unable to give informed consent
- Pregnant patients
- Unable to have cardiac MRI
- Prohibitive procedural risk
- Unable to tolerate the ablation procedure due to haemodynamic instability
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
About this study
Official title: Can MRI-based Computational Modelling of the Heart be Used to Predict Critical Substrate in Scar-dependent Ventricular Tachycardia Ablation?
We aim to improve our understanding of a life-threatening heart rhythm disorder known as ventricular tachycardia (VT). This is a disorder which originates from the lower chamber of the heart and frequently is associated with heart disease. We will use an MRI scan to generate a computer based model of the heart which can predict areas of the heart which are important in generating this rhythm disorder. We intend to assess how accurate this computer model is compared to traditional invasive assessment of the heart muscle. We also aim to assess the electrical characteristics of those areas which were predicted by the computer model in order to see why they were thought to be so important.
All patients seen at St George's Hospital with VT will be eligible. As is routine for these patients, they will have an MRI scan of the heart. We will then use this scan to create a virtual reconstruction of the heart from which predictions of the critical areas of the heart which are generating the rhythm problem will be made. Then we will perform a VT ablation (studying the electrical properties and if necessary making a burn to treat the rhythm problem) - as per standard of care, however during the ablation we will spend extra time collecting information comparing the accuracy of the computer-generated model to the traditional invasive signals which guide ablation. We will study the electrical properties of those predicted areas to see what is special about them. The study will last up to three years.
Read the detailed description
Patients will be eligible for this trial both from referrals as an outpatient, where VT has been detected on a heart rhythm monitor or ECG (electrical heart tracing), or as an inpatient where they have been admitted to hospital with symptoms of VT. Our study investigators will discuss the research with the patient and give them the relevant information in an understandable format as part of a Patient Information Sheet so that they can make an informed decision about whether or not to participate in the research.
An MRI scan of the heart is a standard investigation for patients presenting with VT, however if the patient is included in the study, the MRI scan images will be anonymised and sent confidentially to the Institute of Computational Modelling at Johns Hopkins University in USA where the images will be reconstructed into a 3D representation of the patients heart, where the electrical pathways and source of the VT can be seen. This information will be sent back (again confidentially and anonymously) to St George's Hospital in time for their routine VT ablation procedure.
During the VT ablation The MRI scan model will be combined with the invasively-obtained information and we will assess the various areas of the heart which are responsible for the VT, particularly relating to areas of scar within the heart, which are frequently seen in these patients. We will assess the electrical properties of the areas highlighted as the cause of the VT from the MRI scan.
We will assess the accuracy of the computer model compared to the traditional invasive measurements that we take. We will first ablate those areas of the heart which the model predicted as being important (as long as the invasive characteristics support ablation there) and then see what effect this had on the electrical properties of other areas of the heart. However, we will not ablate any area of the heart based solely on the MRI model; it will only influence the order of ablation and not tell us whether to ablate or not.
The procedure can take 4-6 hours in total. The extra information gathered as part of the research protocol may extend this by a maximum of 10%. No extra pieces of equipment, procedures or medications are involved in the research, just the time taken to generate a computer model of the heart as well as a extra time to assess the heart in more detail during the ablation.
Following the ablation, the patients will be followed at 3, 6 and 12 months with a heart rhythm monitor and a clinical review as an outpatient as per routine standard of care. From this, we will collect data on frequency of recurrence of rhythm disturbance, therapy from their implantable cardioverter-defibrillators, symptoms and complications following the ablation procedure.
The information gathered during the procedure will be analysed and research papers generated from the results.
- Conditions
- Ventricular Tachycardia
- Being tested
- Generation of computational model from cardiac MRI., VT ablation
- Keywords
- ventricular tachycardia, ablation, cardiac MRI, computational modelling
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generation of computational model from cardiac MRI.Diagnostic test
Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques.
VT ablationProcedure or surgery
Routine VT ablation as described elsewhere in the literature. However, a brief period of extra time (~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with scar-dependent ventricular tachycardia, requiring ablation. These patients will have satisfied the inclusion/exclusion criteria and be put forward for VT ablation. They will undergo the previously described study protocol, including generation of a computational model of the heart from their cardiac MRI and a VT ablation where we will study the points of interest generated from the MRI model in detail. Receives: Diagnostic Test: Generation of computational model from cardiac MRI.; Procedure: VT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrogram Duration at Digital Twin Predicted Sites Compared to Non-predicted Sites
Duration of electrograms at digital twin predicted sites compared to non-predicted sites on invasive mapping within areas of bipolar low voltage (<1.5mV)
Measured: During ablation
Secondary outcomes (1)
Symptom Assessment at 12 Month Clinical Follow up
Assessment of patient's symptoms at a clinical consultation following the ablation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Mar 2021
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Magdi Saba, MD, Study director, St George's Hospital / SGULAnthony Li, MD, Study director, St George's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632394
- Sponsor's protocol ID
- 2020.0237
- Status last verified
- Apr 2023
- First submitted
- 20 Oct 2020
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable - participant data will not be shared with other researchers outside the study group.
Publications
Waight MC, Prakosa A, Li AC, Truong A, Bunce N, Marciniak A, Trayanova NA, Saba MM. Comparison of combined anatomic and functional modeling with purely anatomic assessment in scar-dependent ventricular tachycardia. Heart Rhythm. 2026 Apr;23(4):e595-e604. doi: 10.1016/j.hrthm.2026.01.006. Epub 2026 Jan 7.
PubMed 41513062Waight MC, Prakosa A, Li AC, Bunce N, Marciniak A, Trayanova NA, Saba MM. Personalized Heart Digital Twins Detect Substrate Abnormalities in Scar-Dependent Ventricular Tachycardia. Circulation. 2025 Feb 25;151(8):521-533. doi: 10.1161/CIRCULATIONAHA.124.070526. Epub 2025 Jan 6.
PubMed 39758009
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can MRI-based Computational Modelling of the Heart be Used to Predict Critical Substrate in Scar-dependent Ventricular Tachycardia Ablation?
- ClinicalTrials.gov ID
- NCT04632394
- Acronym / sponsor ID
- 2020.0237
- Conditions
- Ventricular Tachycardia
- Keywords
- ventricular tachycardia, ablation, cardiac MRI, computational modelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to improve our understanding of a life-threatening heart rhythm disorder known as ventricular tachycardia (VT). This is a disorder which originates from the lower chamber of the heart and frequently is associated with heart disease. We will use an MRI scan to generate a computer based model of the heart which can predict areas of the heart which are important in generating this rhythm disorder. We intend to assess how accurate this computer model is compared to traditional invasive assessment of the heart muscle. We also aim to assess the electrical characteristics of those areas which were predicted by the computer model in order to see why they were thought to be so important.
All patients seen at St George's Hospital with VT will be eligible. As is routine for these patients, they will have an MRI scan of the heart. We will then use this scan to create a virtual reconstruction of the heart from which predictions of the critical areas of the heart which are generating the rhythm problem will be made. Then we will perform a VT ablation (studying the electrical properties and if necessary making a burn to treat the rhythm problem) - as per standard of care, however during the ablation we will spend extra time collecting information comparing the accuracy of the computer-generated model to the traditional invasive signals which guide ablation. We will study the electrical properties of those predicted areas to see what is special about them. The study will last up to three years.
Detailed description
Patients will be eligible for this trial both from referrals as an outpatient, where VT has been detected on a heart rhythm monitor or ECG (electrical heart tracing), or as an inpatient where they have been admitted to hospital with symptoms of VT. Our study investigators will discuss the research with the patient and give them the relevant information in an understandable format as part of a Patient Information Sheet so that they can make an informed decision about whether or not to participate in the research.
An MRI scan of the heart is a standard investigation for patients presenting with VT, however if the patient is included in the study, the MRI scan images will be anonymised and sent confidentially to the Institute of Computational Modelling at Johns Hopkins University in USA where the images will be reconstructed into a 3D representation of the patients heart, where the electrical pathways and source of the VT can be seen. This information will be sent back (again confidentially and anonymously) to St George's Hospital in time for their routine VT ablation procedure.
During the VT ablation The MRI scan model will be combined with the invasively-obtained information and we will assess the various areas of the heart which are responsible for the VT, particularly relating to areas of scar within the heart, which are frequently seen in these patients. We will assess the electrical properties of the areas highlighted as the cause of the VT from the MRI scan.
We will assess the accuracy of the computer model compared to the traditional invasive measurements that we take. We will first ablate those areas of the heart which the model predicted as being important (as long as the invasive characteristics support ablation there) and then see what effect this had on the electrical properties of other areas of the heart. However, we will not ablate any area of the heart based solely on the MRI model; it will only influence the order of ablation and not tell us whether to ablate or not.
The procedure can take 4-6 hours in total. The extra information gathered as part of the research protocol may extend this by a maximum of 10%. No extra pieces of equipment, procedures or medications are involved in the research, just the time taken to generate a computer model of the heart as well as a extra time to assess the heart in more detail during the ablation.
Following the ablation, the patients will be followed at 3, 6 and 12 months with a heart rhythm monitor and a clinical review as an outpatient as per routine standard of care. From this, we will collect data on frequency of recurrence of rhythm disturbance, therapy from their implantable cardioverter-defibrillators, symptoms and complications following the ablation procedure.
The information gathered during the procedure will be analysed and research papers generated from the results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Generation of computational model from cardiac MRI., Procedure: VT ablationPatients with scar-dependent ventricular tachycardia, requiring ablation. These patients will have satisfied the inclusion/exclusion criteria and be put forward for VT ablation. They will undergo the previously described study protocol, including generation of a computational model of the heart from their cardiac MRI and a VT ablation where we will study the points of interest generated from the MRI model in detail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study setting is a large tertiary centre hospital in London, St George's University Hospital which serves a population of around 1.3 million. It also receives referrals from district general hospitals in the surrounding area. Referrals are made to a specialist arrhythmia clinic from which suitable patients can be identified. The majority of recruited patients are expected to be outpatients who are symptomatic from VT despite optimal medical therapy. This will allow sufficient time to perform the cardiac MRI and to generate the computational model. In some scenarios, emergency admissions with symptomatic VT may be included if they are suitable for inpatient VT ablation and there is sufficient time for the MRI and computation analysis to take place prior to the VT ablation.
Key inclusion criteria (7 listed)
- Adult inpatients admitted to St George's Hospital London with sustained ventricular tachycardia or outpatients identified from the arrhythmia clinic with significant monomorphic ventricular tachycardia noted on cardiac monitoring who:
- Have sustained, monomorphic scar-dependent ventricular tachycardia
- Are symptomatic
- Failed, unable or unwilling to tolerate anti-arrhythmic medications
- Able to have a cardiac MRI
Key exclusion criteria (6 listed)
- Patients under the age of 18
- Patients who are unable to give informed consent
- Pregnant patients
- Unable to have cardiac MRI
- Prohibitive procedural risk
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 |
|---|---|---|
| Generation of computational model from cardiac MRI.Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques. | Diagnostic test | Cases |
| VT ablationRoutine VT ablation as described elsewhere in the literature. However, a brief period of extra time (~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart. | Procedure or surgery | Cases |
Primary outcome
Electrogram Duration at Digital Twin Predicted Sites Compared to Non-predicted Sites
Time frame: During ablation
Duration of electrograms at digital twin predicted sites compared to non-predicted sites on invasive mapping within areas of bipolar low voltage (<1.5mV)
1 secondary outcome
Symptom Assessment at 12 Month Clinical Follow up
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41513062Waight MC, Prakosa A, Li AC, Truong A, Bunce N, Marciniak A, Trayanova NA, Saba MM. Comparison of combined anatomic and functional modeling with purely anatomic assessment in scar-dependent ventricular tachycardia. Heart Rhythm. 2026 Apr;23(4):e595-e604. doi: 10.1016/j.hrthm.2026.01.006. Epub 2026 Jan 7.
- Derived from this study: PubMed 39758009Waight MC, Prakosa A, Li AC, Bunce N, Marciniak A, Trayanova NA, Saba MM. Personalized Heart Digital Twins Detect Substrate Abnormalities in Scar-Dependent Ventricular Tachycardia. Circulation. 2025 Feb 25;151(8):521-533. doi: 10.1161/CIRCULATIONAHA.124.070526. Epub 2025 Jan 6.
- Individual participant dataSharing planned: No. Not applicable - participant data will not be shared with other researchers outside the study group.
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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.
Magdi Saba, MD study director
St George's Hospital / SGUL
Anthony Li, MD study director
St George's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by St George's, University of 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 7 inclusion and 6 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 30 May 2025. 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 30 May 2025). 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?
Electrogram Duration at Digital Twin Predicted Sites Compared to Non-predicted Sites (time frame: During ablation). 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 NCT04632394, 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 30 May 2025.