Ventricular TachycardiaECGI-VTNCT03713866
Peri-Procedural Transmural Electrophysiological (EP) Imaging of Scar-Related Ventricular Tachycardia
A study testing EP Imaging and Testing in people with Ventricular Tachycardia and Myocardial Infarction, run by John Sapp at 1 site in Canada.
Trial summary
Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia, Myocardial Infarction
- What is being tested?
- EP Imaging and Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- One or more episodes of sustained monomorphic VT
- Referred for catheter ablation
- Previously implanted ICD
- Signed the patient informed consent form
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Have estimated Glomerular Filtration Ratio (eGFR) less than 30
- Have a life expectancy less than 6 months or are listed for heart transplantation at time of inclusion
- Are pregnant
- Are on IV inotropic agents
- Have any contraindication to catheter ablation (including but not limited to mechanical prosthetic aortic and mitral valves, known protruding Left Ventricular (LV) thrombus
- New York Heart Association (NYHA) functional class IV
- Had ST wave elevation myocardial infarction within < 1 month
- Unwilling or unable to undergo cardiac MRI scan AND unwilling or unable to undergo cardiac CT scan (e.g. contrast allergy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
QEII HSC
Halifax, Nova Scotia, B3H 3A7
Karen A Giddens, 9024732758, karen.giddens@nshealth.ca
About this study
Official title: Peri-Procedural Transmural Electrophysiological Imaging of Scar-Related Ventricular Tachycardia
Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. An important treatment is to use catheter ablation to "block" the channel that forms the circuit. Effective ablation requires imaging guidance to visualize the VT circuit relative to scar structures in 3D. Unfortunately, with conventional catheter mapping, up to 90% of the VT circuits are too short-lived to be mapped. For the 10% "mappable" VTs, their data are only available during ablation and limited to one ventricular surface. This inadequacy of functional VT data largely limits the knowledge about scar-related VT and ablation strategies, and reduces the ability of clinicians to identify ablation targets and assess ablation outcome.
The central hypothesis of this proposal is that functional VT data, integrated with CT or MRI scar data in 3D, can improve VT ablation efficacy with pre-procedural identification of ablation targets and post-procedural mechanistic elucidation of ablation failure. This research builds on the rapidly increasing clinical interest in electrocardiographic imaging (ECGi), an emerging technique that obtains cardiac electrical activity through inverse reconstructions from ECGs. The specific objective is to push the boundary of ECGi to provide - as a conjunction to intra-procedural catheter mapping - pre-ablation and post-ablation imaging of functional VT circuits integrated with 3D scar structure.
Read the detailed description
Electrocardiographic imaging (ECGi) is an emerging technique to image cardiac electrical activity through inverse reconstructions from body-surface ECGs. After 40 years of active research, the potential of ECGi as a noninvasive adjunct to catheter mapping is gaining rapid attention in the clinical community.
A total of 40 consecutive post-infarction VT patients will be prospectively enrolled and recruited from those who have been referred for catheter ablation of scar-related VT. Within 7 days before the ablation procedure, these patients will undergo noninvasive cardiac CT or MRI imaging and noninvasive programmed stimulation (NIPS) study with simultaneous 120-lead body- surface ECG mapping (pre-ablation NIPS). MRI will be performed for patients with implantable defibrillators for whom it is considered safe to do so. CT imaging will be performed for those with Implantable Cardioverter Defibrillators (ICDs) which are not MRI compatible.
At the time of scheduled ablation, all patients will undergo standard catheter mapping and ablation procedure as a part of standard care. Within 7 days after the ablation procedure, the patients will undergo cardiac MRI imaging and noninvasive programmed stimulation (NIPS) with simultaneous 120-lead body-surface ECG mapping (post-ablation NIPS). For patients who cannot undergo MRI, CT imaging will not be repeated.
At 6 months after the procedure, a follow-up will occur as a part of standard care where outcome data regarding the chronic success of the ablation procedure will be collected and ICD interrogation will be performed. No imaging or mapping is planned at the follow-up.
- Conditions
- Ventricular Tachycardia, Myocardial Infarction
- Being tested
- EP Imaging and Testing
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP Imaging and TestingDiagnostic test
Magnetic Resonance Imaging: pre-procedure imaging is standard care prior to catheter ablation procedures for VT to document anatomy of the heart.
120-Lead Body Surface Mapping: a 120-lead ECG will be recorded using a standardized mapping protocol. 120 disposable radiolucent silver chloride (Ag/AgCl) surface electrodes will be placed on the torso in 18 strips and connected via cables to an advanced acquisition system.
Noninvasive programmed stimulation (NIPS) study will be performed using the patient's implanted defibrillator, and is part of standard practice during a VT catheter ablation.
| Study group | Role | What they receive |
|---|---|---|
| EP Imaging and Testing | Experimental | MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar. Receives: Diagnostic Test: EP Imaging and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Termination of Ventricular Tachycardia
The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.
Measured: Less than 10 minutes post ablation
VT recurrence rate
Any recurring VT occurring within 6 months post procedure
Measured: Less than 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Nov 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Sapp
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority, Rochester Institute of Technology
- Responsible party
- Sponsor-investigator, John Sapp, Nova Scotia Health Authority
- Investigators
- John L Sapp, MD FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713866
- Sponsor's protocol ID
- SAPP006
- Acronym
- ECGI-VT
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2018
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Procedural Transmural Electrophysiological Imaging of Scar-Related Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT03713866
- Acronym / sponsor ID
- ECGI-VT / SAPP006
- Conditions
- Ventricular Tachycardia, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John SappUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority, Rochester Institute of Technology
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Oct 2018 (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.
Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. An important treatment is to use catheter ablation to "block" the channel that forms the circuit. Effective ablation requires imaging guidance to visualize the VT circuit relative to scar structures in 3D. Unfortunately, with conventional catheter mapping, up to 90% of the VT circuits are too short-lived to be mapped. For the 10% "mappable" VTs, their data are only available during ablation and limited to one ventricular surface. This inadequacy of functional VT data largely limits the knowledge about scar-related VT and ablation strategies, and reduces the ability of clinicians to identify ablation targets and assess ablation outcome.
The central hypothesis of this proposal is that functional VT data, integrated with CT or MRI scar data in 3D, can improve VT ablation efficacy with pre-procedural identification of ablation targets and post-procedural mechanistic elucidation of ablation failure. This research builds on the rapidly increasing clinical interest in electrocardiographic imaging (ECGi), an emerging technique that obtains cardiac electrical activity through inverse reconstructions from ECGs. The specific objective is to push the boundary of ECGi to provide - as a conjunction to intra-procedural catheter mapping - pre-ablation and post-ablation imaging of functional VT circuits integrated with 3D scar structure.
Detailed description
Electrocardiographic imaging (ECGi) is an emerging technique to image cardiac electrical activity through inverse reconstructions from body-surface ECGs. After 40 years of active research, the potential of ECGi as a noninvasive adjunct to catheter mapping is gaining rapid attention in the clinical community.
A total of 40 consecutive post-infarction VT patients will be prospectively enrolled and recruited from those who have been referred for catheter ablation of scar-related VT. Within 7 days before the ablation procedure, these patients will undergo noninvasive cardiac CT or MRI imaging and noninvasive programmed stimulation (NIPS) study with simultaneous 120-lead body- surface ECG mapping (pre-ablation NIPS). MRI will be performed for patients with implantable defibrillators for whom it is considered safe to do so. CT imaging will be performed for those with Implantable Cardioverter Defibrillators (ICDs) which are not MRI compatible.
At the time of scheduled ablation, all patients will undergo standard catheter mapping and ablation procedure as a part of standard care. Within 7 days after the ablation procedure, the patients will undergo cardiac MRI imaging and noninvasive programmed stimulation (NIPS) with simultaneous 120-lead body-surface ECG mapping (post-ablation NIPS). For patients who cannot undergo MRI, CT imaging will not be repeated.
At 6 months after the procedure, a follow-up will occur as a part of standard care where outcome data regarding the chronic success of the ablation procedure will be collected and ICD interrogation will be performed. No imaging or mapping is planned at the follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP Imaging and Testing | Experimental | Diagnostic Test: EP Imaging and TestingMRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- One or more episodes of sustained monomorphic VT
- Referred for catheter ablation
- Previously implanted ICD
- Signed the patient informed consent form
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (8 listed)
- Have estimated Glomerular Filtration Ratio (eGFR) less than 30
- Have a life expectancy less than 6 months or are listed for heart transplantation at time of inclusion
- Are pregnant
- Are on IV inotropic agents
- Have any contraindication to catheter ablation (including but not limited to mechanical prosthetic aortic and mitral valves, known protruding Left Ventricular (LV) thrombus
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 |
|---|---|---|
| EP Imaging and TestingMagnetic Resonance Imaging: pre-procedure imaging is standard care prior to catheter ablation procedures for VT to document anatomy of the heart. 120-Lead Body Surface Mapping: a 120-lead ECG will be recorded using a standardized mapping protocol. 120 disposable radiolucent silver chloride (Ag/AgCl) surface electrodes will be placed on the torso in 18 strips and connected via cables to an advanced acquisition system. Noninvasive programmed stimulation (NIPS) study will be performed using the patient's implanted defibrillator, and is part of standard practice during a VT catheter ablation. | Diagnostic test | EP Imaging and Testing |
Primary outcome
Termination of Ventricular Tachycardia
Time frame: Less than 10 minutes post ablation
The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.
VT recurrence rate
Time frame: Less than 6 months post procedure
Any recurring VT occurring within 6 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
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
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.
John L Sapp, MD FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EP Imaging and Testing in people with Ventricular Tachycardia and Myocardial Infarction, run by John Sapp at 1 site in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John L Sapp, MD FRCPC (902 473 4272, john.sapp@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Termination of Ventricular Tachycardia (time frame: Less than 10 minutes post ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.