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

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByHenry Huang, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with Ischemic Cardiomyopathy.

Exclusion Criteria

My heart condition is mainly due to irregular heartbeats.

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

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

My heart condition is not caused by blocked arteries.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: AI-guided ablationExperimental Treatment1 Intervention

Use of AI guidance to conduct the ablation

Group II: non-AI guided ablationActive Control1 Intervention

Ablation without AI guidance, AI values masked to the operator.