Electrophysiological Imaging for Ventricular Tachycardia

(ECGI-VT Trial)

Overseen By Karen A Giddens

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: John Sapp

Must not be taking: IV inotropic agents

Disqualifiers: Low eGFR, Pregnancy, NYHA IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to enhance heart procedures for ventricular tachycardia (VT), a serious heart rhythm disorder. Scientists use electrocardiographic imaging (ECGi), a technique that combines heart activity images with detailed MRI or CT scans, to better identify problem areas before and after surgery. The goal is to improve how doctors target and treat the electrical issues causing VT. Individuals who have experienced ongoing VT episodes, are scheduled for a catheter ablation procedure, and have an implanted defibrillator might be suitable for this trial. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could improve future heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for ventricular tachycardia?

Research has shown that electrocardiographic imaging (ECGi), a new method for examining the heart's electrical activity, has been safely used in people. Studies indicate that ECGi can help doctors better understand heart rhythm issues. One study found that mapping heart rhythms with ECGi did not cause major safety problems.

Another study on a similar treatment showed that this method reduced heart rhythm issues with only minor short-term risks, suggesting that the treatment is generally well-tolerated. While some risks may exist, the evidence so far suggests that using ECGi to guide heart treatments is reasonably safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EP Imaging and Testing for ventricular tachycardia because it introduces advanced imaging techniques to better map and understand heart scars linked to this condition. Unlike standard treatments that mainly focus on medication or invasive procedures like ablation, this approach uses MRI and 120-lead body surface mapping to create a detailed picture of the heart’s electrical activity. By improving the precision of scar mapping, this method could lead to more targeted therapies, minimizing the guesswork and potentially enhancing patient outcomes.

What evidence suggests that electrophysiological imaging is effective for ventricular tachycardia?

Research has shown that electrocardiographic imaging (ECGi), which participants in this trial will undergo as part of EP Imaging and Testing, can map the circuits involved in ventricular tachycardia (VT) more effectively. Studies have found that ECGi captures the heart's electrical activity from outside the body, allowing doctors to visualize VT circuits and scar tissue in 3D, both before and after treatment. In the past, ECGi successfully guided the treatment of heart rhythm issues, aiding in diagnosis and management. By combining ECGi with other imaging methods like CT or MRI, doctors may better pinpoint and treat problem areas in the heart through ablation, which removes the problematic tissue. This approach could lead to better outcomes for patients with VT. ^{1 2 3 6 7}

Who Is on the Research Team?

John L Sapp, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for individuals who have had a heart attack or suffer from rapid, irregular heartbeats known as ventricular tachycardia and are scheduled for catheter ablation. Participants must have experienced sustained VT episodes, have an implantable cardioverter-defibrillator (ICD), and be able to follow the study's procedures. People with severe kidney issues, short life expectancy, listed for heart transplant, pregnant women, those on certain heart medications or with conditions that prevent MRI or CT scans cannot join.

Inclusion Criteria

Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Signed the patient informed consent form

You have had a defibrillator implanted before.

Exclusion Criteria

You have severe heart problems that limit your ability to do everyday activities.

Your kidney function, measured by eGFR, is very low (less than 30).

I am receiving medication through an IV to strengthen my heart muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-ablation Imaging

Participants undergo noninvasive cardiac CT or MRI imaging and noninvasive programmed stimulation (NIPS) study with simultaneous 120-lead body-surface ECG mapping

1 week

1 visit (in-person)

Ablation Procedure

Participants undergo standard catheter mapping and ablation procedure

1 day

1 visit (in-person)

Post-ablation Imaging

Participants undergo cardiac MRI imaging and noninvasive programmed stimulation (NIPS) with simultaneous 120-lead body-surface ECG mapping

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ICD interrogation

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EP Imaging and Testing

Trial Overview The trial is testing EP Imaging and Testing to improve treatment of ventricular tachycardia by using advanced imaging techniques combined with standard care. The goal is to better identify where in the heart's tissue electrical 'short circuits' occur before and after procedures like catheter ablation.

How Is the Trial Designed?

Group I: EP Imaging and Testing Experimental Treatment 1 Intervention

MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.

EP Imaging and Testing is already approved in United States, European Union for the following indications:

Approved in United States as Electrophysiological Imaging for:

• Ventricular Tachycardia
• Scar-related Ventricular Tachycardia

Approved in European Union as Electrophysiological Imaging for:

• Ventricular Tachycardia
• Scar-related Ventricular Tachycardia

Who Is Running the Clinical Trial?

John Sapp

Lead Sponsor

Trials

6

Recruited

730+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Rochester Institute of Technology

Collaborator

Trials

15

Recruited

5,500+

Published Research Related to This Trial

EEG source imaging (ESI) is emerging as a valuable tool for evaluating epilepsy, particularly in surgical planning for patients with focal epilepsy that does not respond to medication.

While ESI shows promise in localizing brain activity and mapping cortical responses, further research is needed to fully establish its clinical value in presurgical evaluations and in identifying critical brain areas near eloquent cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG source imaging in epilepsy--practicalities and pitfalls. Kaiboriboon, K., Lüders, HO., Hamaneh, M., et al.[2021]

Electrical source imaging (ESI) using high-density EEG (hdEEG) is a noninvasive and cost-effective method that can accurately localize the epileptic zone in children with drug-resistant epilepsy, potentially increasing the chances of achieving seizure freedom after surgery.

In the case of a 15-year-old boy with complex seizure symptoms, hdEEG was crucial in planning for intracranial recordings (SEEG) and ultimately guided successful surgical intervention, highlighting its importance in pediatric epilepsy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of high-density EEG (hdEEG) in pre-surgical epilepsy evaluation in children: case report and review of the literature. Quintiliani, M., Bianchi, F., Fuggetta, F., et al.[2023]

Noninvasive electrocardiographic imaging (ECGI) offers high-resolution mapping of the heart's electrical activity, which can help in assessing synchrony and guiding treatments like cardiac resynchronization therapy.

ECGI has potential applications in various heart conditions, including heart failure and arrhythmias, making it a valuable tool for improving patient outcomes in cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic imaging of heart rhythm disorders: from bench to bedside. Rudy, Y., Lindsay, BD.[2018]

In a study involving 52 patients undergoing 69 ECGI procedures for ventricular arrhythmias, both endo-epicardial ECGI systems demonstrated high diagnostic value in localizing arrhythmia origins, with a perfect match rate of 76% and a near match rate of 95%.

The agreement between the two ECGI systems was consistent, showing that both methods are reliable for identifying the source of ventricular arrhythmias, regardless of the cardiac source used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic imaging to guide ablation of ventricular arrhythmias and agreement between two different systems. Parreira, L., Carmo, P., Nunes, S., et al.[2023]

Electric source imaging (ESI) using routine EEG recordings was able to accurately localize the epileptogenic region in 90% of pediatric patients, demonstrating its effectiveness compared to traditional imaging methods like PET and SPECT.

ESI showed particularly high accuracy in cases of extratemporal epilepsy, while its effectiveness in temporal lobe epilepsy was slightly lower, likely due to limitations in standard electrode placement that may miss critical areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG source imaging in pediatric epilepsy surgery: a new perspective in presurgical workup. Sperli, F., Spinelli, L., Seeck, M., et al.[2006]

Using ECG triggering for diffusion-weighted imaging significantly enhances the accuracy of measuring white matter diffusion, as shown in a study with 6 healthy volunteers.

While ECG triggering improves precision, the results indicate that for routine clinical use, non-triggered measurements still provide adequate accuracy for general assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triggering in quantitative diffusion imaging with single-shot EPI. Brockstedt, S., Borg, M., Geijer, B., et al.[2022]

Electroencephalography Source Imaging (ESI) is a promising non-invasive technique for accurately localizing the epileptogenic zone in patients with focal epilepsy, achieving a clinical yield of 73-91% depending on various factors.

Despite its effectiveness, ESI is underutilized in developing countries, with less than 1% of surgical centers employing this method, highlighting a gap in access to advanced pre-surgical evaluation tools for patients with MRI-negative epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG Source Imaging (ESI) utility in clinical practice. Khosropanah, P., Ho, ET., Lim, KS., et al.[2020]

In a study of 25 patients with nonischemic cardiomyopathy who had cardiac resynchronization therapy (CRT) devices, ECGI revealed consistent patterns of electrical dyssynchrony, particularly with significant conduction block lines and steep activation-recovery interval gradients.

Patients with a native QRS duration greater than 130 ms exhibited high electrical dyssynchrony, while those with shorter QRS durations showed variable dyssynchrony; CRT significantly reduced dyssynchrony in responders, indicating its potential effectiveness in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic substrate and intraventricular left ventricular dyssynchrony in nonischemic heart failure patients undergoing cardiac resynchronization therapy. Ghosh, S., Silva, JN., Canham, RM., et al.[2021]

In a study involving 18 patients undergoing catheter ablation for ventricular tachycardia (VT), ECG imaging (ECGI) demonstrated a higher accuracy in localizing the origin of VT compared to a standard 12-lead ECG algorithm, achieving 83.3% accuracy versus 38.9%.

While ECGI effectively identifies regions of interest for VT mapping, it is not precise enough to independently guide catheter ablation procedures without the support of electroanatomical mapping systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of ECG Imaging to Map Hemodynamically Stable and Unstable Ventricular Arrhythmias. Graham, AJ., Orini, M., Zacur, E., et al.[2020]

Electrocardiographic imaging (ECGI) has proven effective in clinical settings for localizing sources of electrical disorders in the heart, particularly for various arrhythmias.

This non-invasive technique has been successfully used to guide catheter ablation procedures for conditions like atrial fibrillation and Wolff-Parkinson-White syndrome, demonstrating its utility in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac mapping in clinical practice: Application to the ablation of cardiac arrhythmias. Dubois, R., Shah, AJ., Hocini, M., et al.[2015]

The noninvasive electrocardiographic imaging (ECGi) system accurately identified the chamber of origin for arrhythmias in 85% of atrial and 92% of ventricular pacing sites in a study involving 9 pigs.

The system showed better accuracy for lateral pacing locations compared to septal locations, indicating its potential effectiveness in mapping arrhythmias before ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatial Accuracy of a Clinically Established Noninvasive Electrocardiographic Imaging System for the Detection of Focal Activation in an Intact Porcine Model. Hohmann, S., Rettmann, ME., Konishi, H., et al.[2020]

Electrocardiographic imaging (ECGI) effectively evaluates electrical dyssynchrony in pediatric heart failure patients with congenital heart disease, helping to identify suitable candidates for cardiac resynchronization therapy (CRT).

ECGI can guide the placement of resynchronization leads to the site of latest electrical activation, potentially improving CRT outcomes, as demonstrated in two patients who underwent successful CRT implantation based on ECGI findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy in pediatric congenital heart disease: insights from noninvasive electrocardiographic imaging. Silva, JN., Ghosh, S., Bowman, TM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2000800/

Electrocardiographic imaging (ECGI), a novel diagnostic ... Here we describe the first case in which ECGI was used in a patient to assist in the diagnosis and management of a tachyarrhythmia, an unusual ventricular ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.120.008255

Mapping Ventricular Tachycardia With ... Evaluation of ECG Imaging to Map Hemodynamically Stable and Unstable Ventricular Arrhythmias. See Article by Graham et al

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03713866

Study Details | NCT03713866 | Peri-Procedural ... 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- ...

4. academic.oup.com academic.oup.com/europace/article/22/10/1447/5880822

Electrocardiographic imaging for cardiac arrhythmias and ... Electrocardiographic imaging (ECGi) is a non-invasive multi-lead ECG-type imaging tool that enhances conventional 12-lead ECG.

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02652-9/fulltext

Noninvasive assessment of the ventricular arrhythmogenic ... Noninvasive identification of slow conduction regions using electrocardiographic imaging (ECGI) could complement LGE-CMR to aid VT risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3182467/

Noninvasive Electroanatomic Mapping of Human ... This paper presents the first noninvasive images of human ventricular arrhythmias using electrocardiographic imaging (ECGI), highlighting the large diversity ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.038261

Phase I/II Trial of Electrophysiology-Guided Noninvasive ... Noninvasive electrophysiology-guided cardiac radioablation is associated with markedly reduced ventricular arrhythmia burden with modest short-term risks.