Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging
NCT06577714 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322
Last updated 2026-04-27
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
Interventions
- DIAGNOSTIC_TEST
-
Electromechanical wave imaging (EWI)
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.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-15
- Primary Completion
- 2029-10-31
- Completion
- 2029-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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