Study of Ablation-Index Guided Scar-Related Ventricular Tachycardia Treatment in Patients with Ischemic Cardiomyopathy
Randomized Trial Comparing AI-Guided vs Standard Ablation Procedures
Led by Rush University Medical Center · Updated on 2025-09-22
100
Participants Needed
5
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Ablation Index AI guidance during radiofrequency catheter ablation RFCA for ventricular tachycardia VT in patients with ischemic cardiomyopathy and prior myocardial infarction. This study aims to test whether AI guidance can shorten the procedural duration compared to conventional ablation methods. The study focuses on improving lesion quality by incorporating power, contact force, and time to better estimate lesion depth during VT ablation in patients with structural heart disease.
Participants will be randomly assigned to one of two groups one receiving VT ablation guided by the Ablation Index and the other undergoing ablation without AI guidance, where AI values are masked from the operator. The AI incorporates power delivery combined with contact force and time to provide a weighted estimate of lesion quality, aiming to improve ablation precision. This trial is single-blinded and multicenter, focusing on procedural duration and safety.
During the study, participants will undergo VT ablation with monitoring of procedural parameters like ablation time, total procedure duration, intravenous fluid use, and fluoroscopy time. Researchers will assess the percentage reduction in ablation time between the AI-guided and non-AI-guided groups. The study will also monitor safety and procedural efficiency. Participant involvement includes follow-up assessments as required until the study completion date in November 2027.
CONDITIONS
Brief Title
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
Research Team
A
Alexander Mazur, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
AI‑Guided Ablation (in trial)
Standard Ablation (in trial)
Non‑AI Catheter Ablation (clinical practice)
What it is
Procedure using ablation‑index guidance to target scar‑mediated ventricular tachycardia
Conventional ventricular tachycardia ablation performed without AI guidance
Established non‑AI catheter ablation as typically performed in clinical practice
Role in trial
Experimental arm randomized to AI‑guided ablation
Active comparator arm randomized to usual ablation approach without AI
Serves as the clinical reference for typical ablation strategy
Primary use
To achieve more efficient ablation of scar‑mediated VT using AI guidance
To ablate scar‑mediated VT with conventional mapping and ablation techniques
To eliminate VT substrate during standard catheter ablation in practice
How it is performed
Performed with ablation‑index software guiding lesion placement
Performed using conventional mapping and manual lesion delivery without AI
Conducted using established mapping and manual ablation workflows in routine care
Evidence status
Effectiveness currently being investigated; results not yet available
Evidence supports reduced VT recurrence and ICD therapies compared with drug therapy
Catheter ablation is guideline‑supported and reduces VT recurrence and ICD shocks
Important risks
Not yet established; procedural risks typical of VT ablation apply
Subject to procedural complications such as bleeding or arrhythmia
Known procedural risks include rare complications from catheter ablation
Important limitations
No clinical outcome data yet; applicability to scar‑mediated VT remains unproven
May be less efficient than AI‑guided approach; potential variability in operator technique
Dependent on operator skill and mapping accuracy; may be time‑consuming
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patient is 18 years old or older
Diagnosed with ischemic cardiomyopathy
Documented sustained scar-related monomorphic ventricular tachycardia by ECG or device interrogation
You will not qualify if you...
Predominant clinical ventricular arrhythmia is PVCs, supraventricular tachycardia, or ventricular fibrillation
Myocardial infarction or cardiac surgery within the past 6 months
Severe mitral regurgitation
Stroke or transient ischemic attack within the past 6 months
Prior ventricular tachycardia substrate ablation within the past 6 months
New York Heart Association functional class IV
Non-ischemic ventricular tachycardia substrate
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure visit
Participants undergo catheter ablation for ventricular tachycardia either guided by Ablation Index (AI) or without AI guidance.
1 procedure visit (in-person)
Follow-up
Duration - Up to several weeks post-procedure as per clinical follow-up
Participants are monitored after the ablation procedure for procedural outcomes and safety assessments.
Approximately 1 to 2 follow-up visits (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results.
Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model.
Timothy Larsen, Jeanne M Du-Fay-de-Lavallaz, Jeffrey R Winterfield...