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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
a point ablation catheter using a pulse field energy
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Freedom from PVC/VT recurrence
Freedom from PVC/VT recurrence 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. (Sustained Focal Tachycardia is defined as that persisting for \> 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope))
Time frame: at 3 months following ablation procedure
Incidence of Adverse events
Safety is measured as incidence of Serious Adverse Device Effects (SADEs)
Time frame: at 3 months following ablation procedure
Incidence of Serious Adverse Events (SAEs)
Safety is measured as incidence of Serious Adverse Events (SAEs)
Time frame: at 3 months following ablation procedure
Incidence of non-serious adverse events
Safety is measured as incidence of non-serious adverse events
Time frame: at 3 months following ablation procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.