Electromechanical Wave Imaging for Cardiac Arrhythmias

(AGAPE Trial)

Overseen By Elaine Y Wan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cognitive impairment, Severe mental illness, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging technique, electromechanical wave imaging (EWI), can improve the diagnosis and treatment of heart rhythm problems, such as atrial tachycardia or atrial flutter. EWI is a non-invasive ultrasound that provides a detailed view of the heart's electrical activity. Participants are divided into two groups: one where doctors use EWI data to guide treatment, specifically ablation guided by precision imaging using EWI, and another where they do not. The trial will assess whether EWI enhances the accuracy of diagnosis and the effectiveness of procedures. Individuals with heart rhythm issues who are already scheduled for an electrophysiology study might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative diagnostic tools that could enhance heart rhythm treatment.

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 electromechanical wave imaging is safe for diagnosing cardiac arrhythmias?

Research has shown that electromechanical wave imaging (EWI) is a safe and non-invasive method. EWI uses ultrasound to create a detailed picture of the heart's electrical activity, similar to the ultrasound used during pregnancy. This means it is generally easy to undergo and doesn't involve cuts or radiation.

Past studies demonstrated that EWI effectively detects heart rhythm problems without harming patients, with no reports of major side effects. This imaging method aims to improve the accuracy of heart procedures, not replace them. Overall, EWI is considered a safe tool for diagnosing heart rhythm issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Electromechanical Wave Imaging (EWI) for cardiac arrhythmias because it offers a new way to guide ablation procedures with precision. Unlike standard treatments that rely on less precise imaging, EWI is an ultrasound-based technique that captures detailed 3D maps of the heart's electrical activity using just one heartbeat. This non-invasive approach could lead to more accurate and effective treatments for arrhythmias, potentially improving patient outcomes by reducing the need for repeat procedures.

What evidence suggests that electromechanical wave imaging is effective for diagnosing cardiac arrhythmias?

Research has shown that Electromechanical Wave Imaging (EWI) excels at detecting and mapping heart rhythm problems. One study found that EWI accurately identified the location of these issues in 96% of cases, significantly outperforming traditional methods like the 12-lead ECG, which was only 71% accurate. In this trial, participants in the 3D EWI arm will receive ablation guided by this advanced imaging technique. EWI uses ultrasound to create a picture of the heart's electrical activity, providing doctors with a clear view of what is happening inside. This technology could enhance treatment precision and effectiveness. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with cardiac arrhythmias who are already scheduled for an electrophysiology study. It's not suitable for those who don't meet the specific inclusion criteria set by the researchers, which are not detailed here.

Inclusion Criteria

Able to give consent for the study

I am scheduled for a heart rhythm test and possibly treatment for my irregular heartbeat.

Exclusion Criteria

Treating physician does not agree with enrollment

I am able to follow the study's requirements without any issues.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Imaging

Participants undergo Electromechanical Wave Imaging (EWI) to generate 3D maps for arrhythmia diagnosis and procedure planning

1-3 days

1 visit (in-person)

Electrophysiology Study and Ablation

Participants undergo an electrophysiology study and catheter ablation, with or without EWI data available for procedure planning

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including comparative analysis of EWI and standard care outcomes

Up to 1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging

Trial Overview The trial tests if electromechanical wave imaging (EWI), a non-invasive ultrasound technique, can help diagnose and treat heart rhythm problems more effectively. Participants will be randomly chosen to have their EWI data used during their procedure planning.

How Is the Trial Designed?

Group I: Standard of Care Active Control 1 Intervention

Ablation without image guided ablation

Group II: 3D EWI Active Control 1 Intervention

Electromechanical Wave Imaging (EWI) is an ultrasound-based technique that takes 10-15 minute to non-invasively image arrhythmias by visualizing the electromechanical wave corresponding to electromechanical coupling. A full 3D EWI noninvasive ultrasound technique which can construct an entire 4 chamber cardiac activation map using a single heartbeat of arrhythmia acquired in one apical transthoracic echocardiographic image.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4291164/

Electromechanical Wave Imaging for Arrhythmias - PMC These results indicate that EWI can be used for the characterization of non-periodic arrhythmia in conditions close to the clinical setting, in ...

2. science.org science.org/doi/10.1126/scitranslmed.aax6111

Noninvasive localization of cardiac arrhythmias using ... This double-blinded clinical study demonstrates that EWI can localize atrial and ventricular arrhythmias including WPW, PVC, AT, and AFL.

3. withpower.com withpower.com/trial/electromechanical-wave-imaging-for-cardiac-arrhythmias-e8aa8

Electromechanical Wave Imaging for Cardiac Arrhythmias ... Electromechanical Wave Imaging (EWI) has been shown to accurately map and locate arrhythmias in the heart, with a 96% success rate in predicting arrhythmia ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)01829-0/pdf

PO-05-185 ELECTROMECHANICAL WAVE IMAGING FOR ... Electromechanical Wave Imaging. (EWI) is a high frame rate ultrasound modality that noninvasively maps the electromechanical (EM) wave in all cardiac chambers.

5. dicardiology.com dicardiology.com/article/electromechanical-wave-imaging-can-correctly-localize-cardiac-arrhythmias

Electromechanical Wave Imaging Can Correctly Localize ... In this study, EWI was able to correctly predict 96% of arrhythmia locations as compared with 71% for 12-lead ECG analyses (unadjusted for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7234276/

Noninvasive localization of cardiac arrhythmias using ... Here, we present electromechanical wave imaging (EWI), a high frame rate ultrasound technique which can noninvasively map with high accuracy the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06577714

Ablation Guided Via Precision Imaging Using Electromechanical ... This proposed clinical trial will determine how electromechanical wave imaging (EWI), a non-invasive ultrasound precision imaging modality, can effectively ...

8. ahajournals.org ahajournals.org/doi/10.1161/circ.122.suppl_21.A21142

Abstract 21142: Electromechanical Wave Imaging for ... In this study, we present and validate in vivo Electromechanical Wave Imaging (EWI) as a tool to map the transmural electromechanical and electrical activation ...