Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 421
- 试验地点
- 79
- 主要终点
- Safety: Number of Participants With at Least One Primary Safety Event
研究概览
简要总结
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
- •A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- •Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- •physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
- •at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR
- •Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
- •physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
- •any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment
- •Age 18 through 80 years old (or older than 18 if required by local law)
排除标准
- •Long-standing persistent AF (continuous AF that is sustained >12 months)
- •Left atrial diameter > 5.0 cm (anteroposterior)
- •Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- •Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- •Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- •Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Presence of any cardiac valve prosthesis
- •Moderate to severe mitral valve stenosis
- •More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
- •Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- •Unstable angina
- •NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE)
- •Primary pulmonary hypertension
- •Rheumatic heart disease
- •Thrombocytosis, thrombocytopenia
- •Any condition contraindicating chronic anticoagulation
- •Active systemic infection
- •Hypertrophic cardiomyopathy
- •Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- •History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- •Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- •Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- •Known allergies or hypersensitivities to adhesives
- •Unwilling or unable to comply fully with study procedures and follow-up
- •Unable to provide own informed consent
研究组 & 干预措施
Pilot
First group of patients enrolled in the study.
干预措施: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (Device)
Pivotal - Roll-In
First patient treated by each physician in the pivotal phase.
干预措施: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (Device)
Pivotal - Paroxysmal AF
Non roll-in patients with paroxysmal AF (intermittent AF).
干预措施: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (Device)
Pivotal - Persistent AF
Non roll-in patients with persistent AF (AF that lasts longer than 7 days).
干预措施: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (Device)
结局指标
主要结局
Safety: Number of Participants With at Least One Primary Safety Event
时间窗: up to 6 months
Primary safety events are: Within 6 months post-ablation: * Pulmonary vein stenosis (≥70% diameter reduction) * Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) * Atrioesophageal fistula Within 30 days of ablation procedure: * Cardiac tamponade/perforation * Cerebrovascular accident * Major bleeding requiring transfusion * Myocardial infarction * Pericarditis requiring intervention * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications requiring intervention * Systemic/pulmonary embolism requiring intervention * Pulmonary edema * Death * Any PulseSelect PFA System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours (excluding recurrent AF/AFL/AT)
Effectiveness: Number of Participants With Treatment Success.
时间窗: up to 12 months
Treatment success is defined as freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic patient activated ambulatory monitoring transmissions through 12 months, and 12-lead ECGs at all follow up visits. Treatment failure is defined as any of the following components: * Acute procedural failure * Documented AF/AT/AFL on Holter/patient activated ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period. * Any subsequent AF surgery or ablation in the left atrium, except for one repeat PVI ablation using PFA within the 90-day blanking period. * Direct current cardioversion for atrial tachyarrhythmia recurrences after the 90-day blanking period. * Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90-day blanking period.
次要结局
- Quality of Life - Change in EQ-5D Score(Baseline to 12 months post-ablation)
- Quality of Life - Change in AFEQT Score(Baseline to 12 months post-ablation)