The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.

The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular

The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia (VT) ablation that integrates myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation.

The STABLE-VT trial aims to integrate myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation. Particularly, we will compare the procedural safety, and acute and long-term clinical efficacy of this imaging-aided VT ablation protocol to standard of care.

Our hypothesis is that patients with ventricular tachycardia (VT) and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration, improved procedural hemodynamic stability, fewer acute major adverse cardiovascular events (MACE), less need for mechanical support, comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure, and at two-year follow-up compared to standard ablation approach. Herein, our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups.

Inclusion Criteria:

• Patients (>18 years old) diagnosed with severely reduced ejection fraction defined as EF≤25% or EF≤ 35% with concurrent NYHA class III/IV heart failure symptoms and/or at least one previous heart failure hospitalization in the previous 6 months) who are referred for VT ablation.
• Patients with moderate to severe RV dysfunction diagnosed on most recent imaging (echo/c-MRI).
• Patients with must have undergone the imaging (c-MRI and/or CT) required for the investigational VT approach to qualify for participation.

Exclusion Criteria:

• Patients in whom Impella/ECMO or anesthesia is indicated prior to or at presentation to the EP lab.
• Patients for whom an informed consent cannot be obtained.
• Patients who are found to be pregnant using detection of human chorionic gonadotropin (hcg) as done as part of standard of care, will be excluded.