treatment of focal ventricular tachycardias using a pulsed field ablation from a point ablation catheter short title focus-pfa

Conditions: Focal Ventricular Arrhythmias; Premature Ventricular Contractions; Ventricular Tachycardias

Summary: the purpose of this study is to examine the use of a point ablation catheter (farapoint, boston scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.

study design - this is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the farapoint catheter. sample size - a total of 30 subjects will be included in this study. all patients will undergo treatment with the study pfa catheter. study population - the target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias. study duration - approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up. participant duration - subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up. primary effectiveness endpoint chronic single-procedure success: defined as a reduction in the burden of premature ventricular contracts (\>80%) for patients treated for pvcs or absence of sustained focal ventricular tachycardia for patients being treated for focal vts without an increase in anti-arrhythmic medications at 3 month follow ups.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation: * patient is planned for a catheter ablation procedure to ablate either: * premature ventricular contractions (pvcs) and a class i or iia indication for catheter ablation of pvcs according to the 2019 hrs/ehra/aphrs/lahrs guidelines * symptomatic sustained monomorphic ventricular tachycardia * able and willing to provide written consent and comply with all testing and follow-up requirements * above 18 years of age exclusion criteria: * documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate) * contraindication to anticoagulation * life expectancy or other disease processes likely to limit survival to less than 12 months. * currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial. * nyha class iv heart failure * severe, untreated coronary artery disease which would preclude infusion of provocative agents * severe aortic stenosis (ava \ 64mmhg) * severe mitral regurgitation. * allergy to contrast which is unable to be adequately pre-medicated. * acute non-cardiovascular illness or systemic infection * thrombocytopenia (platelet count \< 50,000/mm3) or coagulopathy unless corrected * cardiogenic shock unrelated to ventricular arrhythmias * pregnancy or anticipated pregnancy during study follow-up * pvcs or vt, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.

Keywords: ventricular arrhythmias pvcs premature ventricular contractions vt ventricular tachycardias symptomatic sustained monomorphic ventricular tachycardia