Overview
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.
Description
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
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 < 1.0cm, or PG > 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.
