Cardiac Ablation Clinical Trials

• High-risk refractory VT, defined as:

∙ Ischemic and/or nonischemic cardiomyopathy, and

‣ Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation:

∙ A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic

∙ B: ≥1 appropriate ICD shock

∙ C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP

∙ D: sustained monomorphic VT below detection rate of ICD documented by ECG, and

‣ Left ventricular ejection fraction (LVEF) ≤49% and

‣ Previously underwent at least one standard of care CA for VT.

• Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.

• Has failed amiodarone therapy or is intolerant to amiodarone:

‣ Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g).

⁃ Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities.

• Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.

• Presence of an ICD.

• At least 18 years of age (or meets local age of majority).

• Ability to understand and willingness to sign an IRB approved written informed consent document.