Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging

Conditions

• Arrhythmias, Cardiac

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Apr 15, 2025

Status verified

Apr 2026

Primary completion

Oct 31, 2029

Completion

Oct 31, 2029

Study Design

Enrollment

322 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 3D EWI
  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.
• No Intervention: Standard of Care
  Ablation without image guided ablation

Primary Outcome Measure

Proportions of correct predictions for location of arrhythmia in both standard of care ECG reads compared to EWI maps [ Time Frame: Up to 1 week ]

Locations (1)

Find similar trials in New York, NY

Related Studies

• Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
  Recruiting · Icahn School of Medicine at Mount Sinai · New York, New York
• Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
  Recruiting · The Cleveland Clinic · Cleveland, Ohio
• Autoimmune Basis for Postural Tachycardia Syndrome
  Enrolling By Invitation · Vanderbilt University Medical Center · Oklahoma City, Oklahoma
• The Dynamics of Human Atrial Fibrillation
  Recruiting · Stanford University · Stanford, California