Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 30
- 主要终点
- Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
研究概览
简要总结
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
详细描述
The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
- •Subjects who are willing and capable of providing informed consent;
- •Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
- •Subjects who are of legal age to give informed consent specific to the national law.
- •For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
排除标准
- •Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
- •Subjects with any prior left atrium (LA) ablation;
- •Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
- •Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
- •Life expectancy of < 1 year, per investigator's medical judgement.
结局指标
主要结局
Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
时间窗: 12 Months
* Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events. * Death * Myocardial infarction (MI) * Persistent phrenic nerve palsy * Stroke/Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Cardiac tamponade / perforation * Pericarditis * Pulmonary edema * Serious vascular access complications * Heart block * Gastric motility / pyloric spasm disorders * Severe hemolysis with subsequent renal injury or significant anemia * Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure: * Atrial esophageal fistula * Pulmonary vein stenosis (≥ 70% reduction of diameter)
Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.
时间窗: 12 Months
\- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only AND \- Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit: * Occurrence of any Detectable AF, AFL, AT * ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG * Following interventions: * Any cardioversion for AF, AFL or AT * Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD * Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)
Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
时间窗: 12 Months
* Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events. * Death * Myocardial infarction (MI) * Persistent phrenic nerve palsy * Stroke/Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Cardiac tamponade / perforation * Pericarditis * Pulmonary edema * Serious vascular access complications * Heart block * Gastric motility / pyloric spasm disorders * Severe hemolysis with subsequent renal injury or significant anemia * Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure: * Atrial esophageal fistula * Pulmonary vein stenosis (≥ 70% reduction of diameter)
Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.
时间窗: 12 Months
\- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only AND \- Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit: * Occurrence of any Detectable AF, AFL, AT * ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG * Following interventions: * Any cardioversion for AF, AFL or AT * Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD * Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)
次要结局
未报告次要终点