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Electromechanical Wave Imaging for Cardiac Arrhythmias (AGAPE Trial)

N/A

Waitlist Available

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>=18 years of age

Be older than 18 years old

Must not have

Patient is not able to comply with study protocol due to cognitive impairment, severe mental illness, or planned moved during the study period

Patient does not speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use a non-invasive ultrasound imaging technique called electromechanical wave imaging (EWI) to diagnose and understand cardiac arrhythmias better. Participants undergoing electrophysiology study will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since EWI is a diagnostic imaging tool similar to an ultrasound, it's generally considered safe with minimal to no side effects expected from the imaging process itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to follow the study's requirements without any issues.

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I do not speak English or Spanish.

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My heart rhythm is normal during scans, even with physical or medicinal stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of CareActive Control1 Intervention

Ablation without image guided ablation

Group II: 3D EWIActive Control1 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.

0 / 4Eligibility criteria met