Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging

NCT06577714 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: AAAU7964
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (2)

• Proportions of correct predictions for location of arrhythmia in both standard of care ECG reads compared to EWI maps

  A correct prediction is defined as if it correctly identifies the location of the arrhythmia. A correct prediction is defined as if it correctly identifies the location of the arrhythmia. The 3D EWI maps will be generated prior to procedure and acquisition of the image takes usually takes 15 minutes. Data processing will take at least 1-3 days and will be available prior to the start of the electrophysiology study. Comparative analysis of the results from 3D EWI to the 3D high density electroanatomical maps will take place up to 1 week after the procedure to compare the prediction of target ablation to the area of ablation success.

  Up to 1 week

• Proportions of correct predictions for mechanism of arrhythmia in both standard of care ECG reads compared to EWI maps

  A correct prediction is defined as 1) a method correctly identifies an arrhythmia as focal or macro-reentrant The 3D EWI maps will be generated prior to procedure and acquisition of the image takes usually takes 15 minutes. Data processing will take at least 1-3 days and will be available prior to the start of the electrophysiology study. Comparative analysis of the results from 3D EWI to the 3D high density electroanatomical maps will take place up to 1 week after the procedure to compare the predicted mechanism to the invasively acquired activation map revealing the true mechanism of the arrhythmia

  Up to 1 week

Study Arms (2)

3D EWI

ACTIVE COMPARATOR

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.

Diagnostic Test: Electromechanical wave imaging (EWI)

Standard of Care

NO INTERVENTION

Ablation without image guided ablation

Interventions

Electromechanical wave imaging (EWI) DIAGNOSTIC_TEST

EWI is a high-frame rate ultrasound technique that images the electromechanical wave corresponding to the propagation of the onset of myocardial contraction in response to electrical activation, namely electromechanical coupling.

3D EWI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18 years of age
• Able to give consent for the study
• Scheduled for Invasive Electrophysiology Study (EPS) +/- ablation for atrial tachycardia (AT), atrial flutter (AFL), Wolff-Parkinson-White syndrome (WPW) or premature atrial complexes/premature ventricular complexes (PAC/PVCs)

You may not qualify if:

• Patient is not in clinical arrhythmia at the time of scan despite leg lifts, or intravenous isoproterenol/dobutamine infusion
• Patient is not able to comply with study protocol due to cognitive impairment, severe mental illness, or planned moved during the study period
• Treating physician does not agree with enrollment
• Patient does not speak English or Spanish
• Pregnancy

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the data manager and biostatistician will retain the master list that identifies the randomization allocation and be unblinded. The Data Safety and Monitoring Board and all those who contact patients, the steering PIs, and advisory committee will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)