Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 26
- 主要终点
- Safety event-free rate
研究概览
简要总结
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
详细描述
STUDY OBJECTIVE(S) -- To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
PRIMARY OBJECTIVE -- To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
INDICATION(S) FOR USE -- Study devices will be used per approved Indications for Use for each geography.
DEVICES / SYSTEM USED IN THE STUDY -- The study will include the following Boston Scientific Open-Irrigated Catheters in geographies where commercially approved for PAF ablation:
- Blazer Open-Irrigated Ablation Catheter
- IntellaNav Open-Irrigated Ablation Catheter
- IntellaNav MiFi Open-Irrigated Ablation Catheter
- IntellaTip MiFi Open-Irrigated Ablation Catheter
- Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions.
- IntellaMap Orion Catheter
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment.
- •Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines
- •Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines
- •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
- •Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law.
排除标准
- •Subjects enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
- •Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study
- •Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
- •Subjects who have undergone any cardiac ablation within 30 days prior to enrollment
- •Unrecovered/unresolved Adverse Events from any previous invasive procedure
- •Life expectancy <= three years per physician opinion
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
- •Known cardiac thrombus within 60 days prior to enrollment
- •History of CVA, TIA or PE within 90 days prior to enrollment
- •Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment
- •Implanted Left atrial appendage closure device prior to the index procedure
- •Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair)
- •Left atrial diameter greater than 5.5cm
- •Documented or suspected stenosis of any pulmonary veins.
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Contraindication for anticoagulation
- •Clinically significant mitral valve regurgitation or stenosis per investigator discretion.
- •Any cardiac surgery ≤ 90 days from consent date.
- •Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.
结局指标
主要结局
Safety event-free rate
时间窗: 12 months
The primary safety endpoint is defined as the safety event-free rate at 12 months post-procedure. Primary safety events will consist of a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3 or 12 months post-procedure).
Event Free Rate (Primary)
时间窗: 12 Months
The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed any AAD\* * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence
次要结局
- Event Free Rate (Secondary)(12 Months)