Ablation Index-guided treatment for ventricular tachycardia in heart disease patients
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial
This study tests whether using a new technology to guide heart procedures can help people with heart disease and fast heartbeats feel better and have fewer problems later on compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Trial ID | NCT06138873 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Ablation Index (AI)-guided catheter ablation for treating ventricular tachycardia in patients with ischemic cardiomyopathy. The study compares outcomes of AI-guided ablation to traditional methods without AI guidance. By utilizing advanced technology to monitor lesion quality and depth during the procedure, the trial aims to improve patient outcomes and reduce the recurrence of arrhythmias. The research is particularly focused on patients with structural heart disease and prior myocardial infarction.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with ischemic cardiomyopathy and documented sustained scar-related monomorphic ventricular tachycardia.
Not a fit: Patients with predominantly PVCs, recent myocardial infarction, severe mitral regurgitation, or those with non-ischemic VT substrate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of ventricular tachycardia, reducing the risk of arrhythmia recurrence and improving quality of life for patients.
How similar studies have performed: Previous studies have shown success with AI-guided approaches in other types of arrhythmias, but this specific application for ventricular tachycardia in patients with structural heart disease is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 y.o. * Structural Heart Disease: Ischemic Cardiomyopathy * Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation Exclusion Criteria: * If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation * Myocardial infarction or cardiac surgery within 6 months * Severe mitral regurgitation * Stroke or TIA within 6 months * Prior VT substrate ablation in the previous 6 months * NYHA functional class IV * Non-ischemic VT substrate
Where this trial is running
Chicago, Illinois and 4 other locations
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Mass General Brigham and Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Medical University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexander Mazur, MD — Rush University Medical Center
- Study coordinator: Alexander Mazur, MD
- Email: alexander_mazur@rush.edu
- Phone: 312-942-5020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.