MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

LGE-MRI-integrated EAM-guided catheter ablation: Radiofrequency catheter ablation of ventricular tachycardia guided by LGE-MRI (ADAS-3D) image integration with the EnSite X electroanatomical mapping system.

Conventional EAM-guided catheter ablation: Radiofrequency catheter ablation of ventricular tachycardia guided by electroanatomical mapping alone (EnSite X system), without MRI image integration.

Study summary

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that frequently occurs in patients with structural heart disease, such as ischemic or non-ischemic cardiomyopathy. In these patients, VT usually arises from re-entrant circuits within or around scar tissue in the heart muscle. Catheter ablation, which uses radiofrequency energy to eliminate the abnormal tissue responsible for VT, is an established treatment. However, its long-term success rate remains modest (about 40-60%), partly because conventional three-dimensional electroanatomical mapping (EAM) relies on voltage measurements that cannot fully reveal the complex three-dimensional scar architecture that drives the arrhythmia.

Cardiac magnetic resonance imaging (MRI) with late gadolinium enhancement (LGE) can visualize myocardial scar in high detail before the procedure. Dedicated software (ADAS-3D) converts these MRI scans into a patient-specific three-dimensional model of the scar, including the "heterogeneous tissue channels" of surviving muscle within the scar that are the likely source of VT. This model can be integrated into the mapping system during the ablation procedure, potentially allowing operators to identify and treat the critical tissue more precisely.

This prospective, multi-center, single-blind, randomized controlled trial is testing whether adding LGE-MRI guidance to conventional electrical mapping improves the outcomes of VT ablation. Adults aged 18 to 75 years with structural heart disease and documented sustained VT will undergo cardiac MRI screening. Those with visible scar (LGE-positive) will be randomly assigned in a 1:1 ratio to one of two groups: ablation guided by LGE-MRI integrated with electroanatomical mapping (experimental group), or ablation guided by electroanatomical mapping alone without image integration (control group, with operators blinded to the MRI findings). Patients without scar on MRI will be followed in a separate observational registry.

All participants will be monitored in hospital for at least 24 hours after the procedure and will attend clinic visits at 3, 6, and 12 months. VT recurrence will be monitored with wearable smart ECG devices (worn for at least 7 days at each follow-up) and, in patients with an implantable cardioverter-defibrillator (ICD), by device interrogation. The main goal of the study is to determine whether MRI-guided ablation reduces the combined risk of VT recurrence, cardiovascular hospitalization, or death during 12 months of follow-up compared with standard ablation. The study also assesses procedure-related complications.

Eligibility

Primary outcome measure(s)

• Composite of ventricular tachycardia recurrence, cardiovascular hospitalization, or death — 12 months after the ablation procedure
  VT recurrence is defined as any appropriate ICD therapy (shock or antitachycardia pacing) or documented sustained monomorphic VT lasting more than 30 seconds. Cardiovascular hospitalization is defined as hospital admission after the randomly assigned procedure due to heart failure, procedure-associated complications, or arrhythmic causes.

Trial sites (1)

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