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

322 Participants Needed

Trial Summary

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 Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging?

Electromechanical Wave Imaging (EWI) has been shown to accurately map and locate arrhythmias in the heart, with a 96% success rate in predicting arrhythmia locations compared to 71% for traditional ECG methods. This suggests that EWI can improve the precision of treatments like ablation by better identifying the areas of the heart that need to be targeted. ^{1 2 3 4 5}

Is Electromechanical Wave Imaging (EWI) safe for humans?

Electromechanical Wave Imaging (EWI) is a non-invasive ultrasound technique that has been tested in both animals and humans. Studies have shown it can reliably map heart activity without the need for invasive procedures, suggesting it is generally safe for human use. ^{2 4 6 7 8}

How does Electromechanical Wave Imaging differ from other treatments for cardiac arrhythmias?

Electromechanical Wave Imaging (EWI) is unique because it is a non-invasive ultrasound-based technique that maps the heart's electrical activity by capturing the mechanical waves generated by electrical activation. Unlike traditional imaging methods, EWI provides real-time, high-resolution maps of the heart's electrical function in a single heartbeat, which can help in the early detection and treatment planning of arrhythmias. ^{1 4 7 9 10}

What is the purpose of this trial?

Atrial and ventricular cardiac arrhythmias are serious public health problems in the United States, affecting over 5% of Americans and are major causes of stroke and heart failure leading to increased morbidity and mortality. This proposed clinical trial will determine how electromechanical wave imaging (EWI), a non-invasive ultrasound precision imaging modality, can effectively diagnose and determine the mechanism of the arrhythmia and impact personalized treatment of cardiac arrhythmias. Participants who are already scheduled for electrophysiology study will receive EWI prior to their study. Half of participants will randomly have their EWI imaging data available for their electrophysiologist to analyze and potentially affect procedure planning and execution. Across all participants the results of EWI and the electrophysiology study will be compared to determine EWI accuracy at diagnosing arrhythmias. Participants whose electrophysiologists had access to EWI data will be compared against those without access to determine if EWI data led to improved procedure efficiency and outcomes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Electromechanical wave imaging for arrhythmias. [2023]

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

Validation of electromechanical wave imaging in a canine model during pacing and sinus rhythm. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Non-invasive Characterization of Focal Arrhythmia with Electromechanical Wave Imaging in Vivo. [2019]

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

Electromechanical wave imaging for noninvasive mapping of the 3D electrical activation sequence in canines and humans in vivo. [2021]

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

Noninvasive localization of cardiac arrhythmias using electromechanical wave imaging. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Electromechanical wave imaging (EWI) validation in all four cardiac chambers with 3D electroanatomic mapping in canines in vivo. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Reproducibility and Angle Independence of Electromechanical Wave Imaging for the Measurement of Electromechanical Activation during Sinus Rhythm in Healthy Humans. [2019]

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

A clinical feasibility study of atrial and ventricular electromechanical wave imaging. [2021]

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

Assessing the atrial electromechanical coupling during atrial focal tachycardia, flutter, and fibrillation using electromechanical wave imaging in humans. [2018]

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

Imaging the electromechanical activity of the heart in vivo. [2021]