First-in-Human Experience Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The primary safety endpoint
研究概览
简要总结
This clinical trial aims to evaluate the safety and effectiveness of pulmonary vein isolation (PVI) and linear ablation using a large-focal pulsed field ablation (PFA) catheter in patients with persistent atrial fibrillation (perAF). The study will address two primary questions:
- Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation?
- Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping?
Study Design and Intervention
Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions.
Participant Follow-up Protocol
Enrolled participants will complete the following assessments:
- Index Procedure: PVI and linear ablation with the PFApple PFA catheter.
- Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability.
- Clinical Follow-up: Scheduled visits at 7 days, 30 days, 3 months, 6 months, and 12 months post-procedure. Atrial tachyarrhythmia recurrence is assessed via 12-lead electrocardiography at each visit and 24-hour or 7-day Holter monitoring at the 6- and 12-month time points.
详细描述
Introduction
Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide. Pulmonary vein isolation (PVI) is the established cornerstone therapy for symptomatic, drug-refractory AF. However, for persistent AF (PerAF), the efficacy of PVI alone is reduced compared to its effect in paroxysmal AF. Consequently, adjunctive ablation strategies beyond PVI are often employed in PerAF treatment.
Radiofrequency ablation remains the predominant conventional thermal technique for PerAF. However, its extensive application risks collateral tissue damage and procedure-related complications. These risks present significant challenges to achieving complete, transmural lesions, which may compromise overall ablation efficacy.
Pulsed field ablation (PFA) is an emerging non-thermal technology that induces rapid lesion formation via irreversible electroporation. This modality demonstrates high myocardial selectivity, effectively ablating cardiac tissue while sparing adjacent structures. Preclinical and clinical studies of PFA for PVI report durable lesions and an excellent safety profile, with no evidence of collateral damage. A PVI-plus-additional-ablation (PVI+) strategy is commonly used for PerAF to improve arrhythmia-free survival. However, data on the feasibility and safety of PFA for adjunctive PVI+ ablation remain limited. Whether PFA can enhance the safety and efficacy of PVI+ strategies in PerAF requires further investigation.
This first-in-human study aims to evaluate the feasibility and safety of a novel balloon-shaped, large-focal PFA catheter for PVI+ strategies in patients with PerAF.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years with documented symptomatic PerAF (AF duration: 7 to 365 days), who were either refractory to or intolerant of at least one Class I or III antiarrhythmic drug and willing to provide informed consent.
排除标准
- •Paroxysmal atrial fibrillation (AF)
- •AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
- •Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
- •Patients with sustained ventricular tachycardia or ventricular fibrillation
- •Left atrial anteroposterior diameter > 55 mm
- •Pulmonary vein (PV) stenosis (>70%) or prior PV stent implantation
- •History of left atrial ablation or cardiac surgery (including left atrial appendage closure)
- •Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)
- •Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities
- •Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities
- •Any of the following cardiac surgeries, implants, or conditions:
- •Prosthetic heart valve
- •NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) < 40%
- •Atrial septal defect or ventricular septal defect closure
- •Atrial myxoma, left atrial appendage device implantation or occlusion
- •History of any of the following within 3 months prior to the procedure:
- •Myocardial infarction
- •Unstable angina
- •Percutaneous coronary intervention
- •Cardiac surgery (including coronary artery bypass grafting)
- •Hospitalization for heart failure
- •Pericarditis
- •History of any of the following within 3 months prior to the procedure:
- •Cerebral infarction or transient ischemic attack (TIA)
- •Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography [TEE])
- •History of malignant tumor or expected life expectancy < 12 months
- •Mental disorders or history of mental illness with inability to cooperate independently
- •Lactating, pregnant, or women planning or potentially becoming pregnant
- •Acute or severe systemic infection, or significant abnormalities in liver/renal function
- •Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator
结局指标
主要结局
The primary safety endpoint
时间窗: 3 months post-ablation
The primary safety endpoint of this pilot study was the occurrence of primary adverse events within 7 days after the index ablation procedure. Device- or procedure-related death, atrio-oesophageal fistula, and PV stenosis occurring more than 7 days post-ablation were also classified as primary adverse events. Diaphragmatic paralysis/phrenic nerve palsy were considered PAEs if symptoms persisted at the 3-month follow-up visit.
The primary efficacy endpoint
时间窗: Immediately post-ablation
The primary efficacy endpoint was the acute procedural success rate, defined as the proportion of patients who achieved all of the following: 1) complete electrical isolation of all PVs after PVI; 2) for patients undergoing additional linear ablation, bidirectional block confirmed at the targeted linear sites (LAPW, MI, or CTI).
次要结局
- The secondary efficacy endpoints(One year post-ablation)
研究者
Hanxiong Liu
Professor
The Third People's Hospital of Chengdu