Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT
研究概览
简要总结
The investigators will prospectively evaluate the extent of antral lesion created by the 31 mm balloon size of a novel cryoballoon catheter (POLARx FIT). In 20 patients with paroxysmal atrial fibrillation, the investigators will perform pre- and post-ablation high-definition 3D maps to quantify the extent of lesion created by the 31 mm POLARx FIT cryoballoon.
详细描述
Rationale: The next generation POLARx cryoablation balloon (CB) catheter will have the option of to deliver cryotherapy with the current balloon size of 28 mm or a new, larger 31 mm size by changing the inner balloon pressure (POLARx FIT, Boston Scientific). Currently, there is no data on the extension of left atrial (LA) lesion formation with the 31 mm balloon size of the POLARx FIT cryoablation balloon catheter. The hypothesis is that a larger CB size results in a wide antral circumferential lesion.
Objective: The primary objective is to evaluate the antral lesion size using ultrahigh-density (UHDx) mapping pre- and post-cryoablation with the 31 mm balloon size CB. Secondary objectives are the proportion of pulmonary veins (PVs) where a 31 mm CB could be positioned to achieve a grade 4 occlusion and the single shot success rate with the 31 mm balloon size CB.
Study design: Single-center, single-arm, prospective study with pre- and post-PVI UHDx mapping.
Study population: Twenty adult patients with paroxysmal AF who are scheduled to undergo pulmonary vein isolation (PVI) with a CB.
Intervention: Patients will undergo pre- and post-ablation UHDx mapping (Orion catheter and Rhythmia 3D-mapping system, Boston Scientific) during the index procedure.
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
- •History of symptomatic paroxysmal AF
- •Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
- •Subjects who are willing and capable of providing informed consent
- •Subjects who are willing and capable of participating in all testing associated with this clinical investigation
- •Subjects whose age is 18 years or above
排除标准
- •Any known contraindication to an AF ablation or anticoagulation
- •History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
- •AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- •Significant structural heart disease as evidenced by:
- •Left ventricular ejection fraction <45% based on most recent transthoracic echocardiogram (TTE) performed <6 months prior to enrollment
- •LA diameter >55 mm based on most recent TTE performed <6 months prior to enrollment
- •Previous cardiac surgery
- •Previous cardiac valvular surgical or percutaneous procedure
- •Interatrial baffle, closure device, patch, or occluder
- •Unstable angina or ongoing myocardial ischemia
- •Moderate or severe valvular heart disease on most recent TTE performed <6 months prior to enrolment
- •Congenital heart disease
- •Left atrial thrombus
- •History of blood clotting or bleeding disease
- •Stroke or transient ischemic attack <3 months prior to enrollment
- •Active systemic infection
- •Common ostium PV >24 mm defined by CT-scan
- •Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
研究组 & 干预措施
Study population
This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size.
干预措施: POLARx FIT cryoballoon (Device)
结局指标
主要结局
Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT
时间窗: Interprocedural (directly after cryoablation)
Low-voltage areas will be quantified using a bipolar voltage \<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.
次要结局
- Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT(Interprocedural (before cryoablation))
- Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter(Interprocedural (directly after cryoablation))
研究者
Sing-Chien Yap, MD, PhD
Cardiologist-electrophysiologist
Erasmus Medical Center