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Procedure

AI-Guided Ablation for Ventricular Tachycardia in Heart Disease (AIM-VT Trial)

N/A

Waitlist Available

Led By Henry Huang, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Patient must be 18 years or older

Patient must have Ischemic Cardiomyopathy

Must not have

Clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation

Severe mitral regurgitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if using a new measure (AI) of lesion quality during ablation for ventricular arrhythmias (VA) improves outcomes for patients with heart disease.

Who is the study for?

This trial is for adults over 18 with Ischemic Cardiomyopathy who've had a specific type of irregular heartbeat (Scar-related Monomorphic Ventricular Tachycardia) confirmed by ECG or device check. It's not for those with other heart rhythm problems, recent heart attacks or surgery, severe valve issues, recent stroke/TIA, the worst class of heart failure symptoms, or non-ischemic causes.

What is being tested?

The study compares two ways to treat irregular heartbeats using radiofrequency catheter ablation: one group gets standard treatment without Ablation Index guidance and the other uses AI-guidance aiming for more precise lesion creation. The goal is to see if AI-guidance shortens procedure time.

What are the potential side effects?

Potential side effects from ventricular tachycardia ablation can include discomfort at the site where catheters are inserted, bleeding or bruising there, damage to blood vessels or heart tissue during the procedure and risks associated with sedation.

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.

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I have been diagnosed with Ischemic Cardiomyopathy.

Exclusion Criteria

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

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My heart condition is mainly due to irregular heartbeats.

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I have severe leakage in my heart's mitral valve.

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I have had a procedure to treat irregular heartbeats in the last 6 months.

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My heart condition is not caused by blocked arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

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

Treatment Details

Study Objectives

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

Primary study objectives

Percentage reduction in ablation time between the groups with/without AI guidance

Secondary study objectives

Fluoroscopy duration in minutes

Percentage of reduction in total procedural duration in seconds between the AI/not AI group

Total intravenous fluids administered in milliliters (ml)

Other study objectives

Ablation Index per lesion (absolute value and percentage difference)

Acute procedural success (no inducible VT), partial success (only non-clinical VT induced), and inducibility not tested at end of procedure (in number, % and risk-difference)

Average ablation time per lesion (in seconds and percentage difference)

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