First-in-Human Experience Using a Novel Shape-Adaptive Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary safety endpoint
研究概览
简要总结
Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF).
The main questions it aims to answer are:
- Is there an absence of serious procedure or device-related adverse events within 7 days?
- Can the catheter achieve durable lesions?
This trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical).
Participants will:
- Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia;
- Undergo remapping within 3-month post the index ablation to assess the durability of the lesions;
- Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.
详细描述
Background
Catheter ablation with thermal energy sources, including radiofrequency (RF) or cryoablation, is a well-established and effective treatment for atrial fibrillation (AF), demonstrating comparable safety and efficacy in studies where pulmonary vein isolation (PVI) is the procedural endpoint. However, the non-selective diffusion of thermal energy risks collateral damage to adjacent anatomical structures, a limitation for both clinical application and technological advancement. These two catheter types each present distinct trade-offs: point-by-point RF ablation requires considerable operator skill and longer procedure times, while cryoballoon ablation, though more user-friendly, lacks precise spatial control and is less suited for mapping and ablating non-PVI targets.
Pulsed field ablation (PFA) employs high-voltage, ultra-rapid electric fields to induce irreversible electroporation and cellular death. As a non-thermal modality, PFA demonstrates preferential selectivity for cardiomyocytes. This offers the potential to create durable lesions while better preserving surrounding critical structures such as the esophagus, blood vessels, pulmonary veins, and phrenic nerve. Notably, PFA has not been associated with thermal complications like atrioesophageal fistula, phrenic nerve palsy, or pulmonary vein stenosis, suggesting it may enhance PVI effectiveness while reducing procedural risks.
Current evidence for PFA in AF management stems largely from preclinical studies and single-arm clinical trials. Early first-in-human studies with various PFA systems have reported promising outcomes. In the pivotal single-arm PULSED AF trial, PFA (PulseSelect System, Medtronic) for paroxysmal and persistent AF yielded arrhythmia recurrence rates comparable to thermal ablation, with a low rate of primary safety events at one year. The MANIFEST-PF registry reported a 99.9% acute PVI success rate, very low major complications, and reduced atrial arrhythmia recurrence relative to thermal ablation.
A recent randomized controlled trial (RCT) in persistent AF (ADVENT trial) found PFA (Farapulse System, Boston Scientific) non-inferior to conventional thermal ablation for the primary efficacy endpoint-freedom from procedural failure and post-procedural atrial tachyarrhythmias. Another RCT in persistent AF (Sphere-Per-AF trial) confirmed that PFA (Sphere-9 System, Medtronic) was comparable to thermal ablation in both effectiveness and safety, with the added advantage of shorter procedure times.
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
- •1. Aged between 18 and 75 years (inclusive), regardless of gender
- •Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets **any one** of the following criteria:
- •A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
- •Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.
- •3. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs.
- •4. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.
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: Seven days post index ablation procedure
The primary safety endpoint was the incidence of primary adverse events (PAEs) within 7 days post-ablation. Later-occurring events (device/procedure-related death, atrio-esophageal fistula, PV stenosis) were also classified as PAEs. Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months were considered PAEs.
The primary efficacy endpoint
时间窗: Immediately after the index ablation procedure
The primary efficacy endpoint was acute procedural success, defined as the proportion of patients achieving: 1) complete electrical isolation of all PVs, and 2) for those undergoing linear ablation, confirmed bidirectional block at all targeted sites (LAPW, MI, CTI).
次要结局
- Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint](Immediate after the index ablation procedure)
- Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint](Immediate after the index ablation procedure)
- Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint](3 months after the index ablation procedure)
- 1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint](1 year after the index ablation procedure)
研究者
Hanxiong Liu
Professor
The Third People's Hospital of Chengdu