ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 7
- 主要终点
- Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
研究概览
简要总结
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
- •Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD);
- •Eligible for an ablation procedure with the Rhythmia HDx mapping system (software version 2.0 or any future commercially available Software Version), IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter according to current international and local guidelines (and future revisions) and per physician discretion;
- •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 at an approved clinical investigational center;
- •Age 18 to 80
排除标准
- •• Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment:
- •New York Heart Association (NYHA) Class III or IV
- •Left ventricular ejection fraction (LVEF) <35%
- •Left atrial (LA) diameter >5.5 cm
- •Unstable angina or ongoing myocardial ischemia (OMI)
- •Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
- •Active systemic infection or sepsis;
- •Undergone any left atrial heart ablation procedure, either surgical or catheter ablation
- •Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
- •Subject has a Left Atrial Appendage Closure (LAAC) or Percutaneous Transcatheter Closure of a Patent Foramen Ovale (PFO)
- •Subject has persistent or long-standing persistent atrial fibrillation (AF) ( >1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year)
- •Life expectancy ≤ 6 months per physician judgment
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility;
- •The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
结局指标
主要结局
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
时间窗: Day 0 and 3 months
Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment\* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. \*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
次要结局
- Local Impedance in Segments With Maximum Number of Gaps at Day Zero(Day 0)
- Local Impedance and Local Impedance Change and PVI Gaps at Day Zero(Day 0)
- Number of Gaps at Day Zero(Day 0)
- Baseline Local Impedance and Local Impedance Change at Day Zero(Day 0)
- Maximum Number of Gaps Per PV Segment at Day Zero(Day 0)