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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EP Imaging and Testing, Electrophysiological Imaging, EP Testing, Electrocardiographic Imaging (ECGi) for Ventricular Tachycardia?

While the research does not directly address Ventricular Tachycardia, similar imaging techniques like EEG Source Imaging (ESI) have shown promise in accurately identifying electrical activity in the brain for epilepsy treatment. This suggests that advanced imaging techniques could potentially be useful in mapping electrical activity in the heart for conditions like Ventricular Tachycardia. ^{1 2 3 4 5}

Is electrocardiographic imaging (ECGI) safe for use in humans?

Electrocardiographic imaging (ECGI) has been used in clinical settings for over ten years to map heart rhythms and guide treatments for various heart conditions, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How is the treatment 'Electrophysiological Imaging and Testing' different from other treatments for ventricular tachycardia?

Electrophysiological Imaging and Testing, also known as Electrocardiographic Imaging (ECGi), is unique because it is a non-invasive method that maps the electrical activity on the heart's surface with high resolution. This allows doctors to precisely locate the source of arrhythmias, which can guide more effective treatment decisions, such as catheter ablation, compared to traditional methods that may not provide such detailed information. ^{6 7 9 11 12}

Research Team

John L Sapp, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

EEG source imaging in epilepsy--practicalities and pitfalls. [2021]

2. Germany 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

EEG source imaging in pediatric epilepsy surgery: a new perspective in presurgical workup. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Triggering in quantitative diffusion imaging with single-shot EPI. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

EEG Source Imaging (ESI) utility in clinical practice. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Electrophysiologic substrate and intraventricular left ventricular dyssynchrony in nonischemic heart failure patients undergoing cardiac resynchronization therapy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac mapping in clinical practice: Application to the ablation of cardiac arrhythmias. [2015]

8. United States 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy in pediatric congenital heart disease: insights from noninvasive electrocardiographic imaging. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic imaging to guide ablation of ventricular arrhythmias and agreement between two different systems. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of ECG Imaging to Map Hemodynamically Stable and Unstable Ventricular Arrhythmias. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic imaging of heart rhythm disorders: from bench to bedside. [2018]