Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging
NCT Number: NCT06577714
Acronym: AGAPE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arrhythmias, Cardiac
Interventions: DIAGNOSTIC_TEST: Electromechanical wave imaging (EWI)
Sponsor: Columbia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 322
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-10
Locations: Columbia University, New York, New York, 10032, United States

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.

Primary Outcome Measures: 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