Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Freedom from PVC/VT recurrence
研究概览
简要总结
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.
详细描述
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 60 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Ablation using study catheter
All patients will undergo a standard ablation protocol using the study catheter (Farapoint)
干预措施: Point Ablation Catheter (Device)
结局指标
主要结局
Freedom from PVC/VT recurrence
时间窗: at 3 months following ablation procedure
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))
次要结局
- Incidence of Adverse events(at 3 months following ablation procedure)
- Incidence of Serious Adverse Events (SAEs)(at 3 months following ablation procedure)
- Incidence of non-serious adverse events(at 3 months following ablation procedure)
研究者
Vivek Reddy
Director Arrhythmia Service MSHS
Icahn School of Medicine at Mount Sinai