Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial
Rush University Medical Center
Summary
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.
Description
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). RFCA uses electromagnetic energy that transforms into heat upon delivery into the myocardium and irreversibly damages the viable myocytes, causing the loss of cellular excitability. Irreversible loss of cellular excitability generally occurs at temperatures exceeding 50°C, while at lower temperatures, the damage is not permanent and myocytes can recover excitability, leading to VA recurrences. Due to the challenging nature of visualizing lesion formation in real t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureAblation-index guided ventricular tachycardia ablation
As described in arms descriptions
- ProcedureVentricular tachycardia ablation with no AI-guidance
As described in arms descriptions
Locations (5)
- Rush University Medical CenterChicago, Illinois
- Mass General Brigham and Women's HospitalBoston, Massachusetts
- Medical University of MichiganAnn Arbor, Michigan
- Mayo ClinicRochester, Minnesota
- Medical University of South CarolinaCharleston, South Carolina