The challenge of optimising ablation lesions in catheter ablation of ventricular tachycardia.
Riccardo Proietti, Luca Lichelli, Nicolas Lellouche...
https://pubmed.ncbi.nlm.nih.gov/33664896Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06138873
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - Prospective Single-Blinded, Multicenter Randomized Controlled Trial
Led by Rush University Medical Center · Updated on 2025-09-22
100
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Rush University Medical Center
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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)
Trial Site Locations
Total: 5 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60614
Actively Recruiting
2
Mass General Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Medical University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
5
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
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Research Team
A
Alexander Mazur, MD
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
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...
https://pubmed.ncbi.nlm.nih.gov/35048448Use 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.
Ahmed Hussein, Moloy Das, Stefania Riva...
https://pubmed.ncbi.nlm.nih.gov/30354288Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study.
Alessio Gasperetti, Rita Sicuso, Antonio Dello Russo...
https://pubmed.ncbi.nlm.nih.gov/33063099Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis.
Alexander P Bates, John Paisey, Arthur Yue...
https://pubmed.ncbi.nlm.nih.gov/36371330