Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint]
研究概览
简要总结
This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical).
The primary study objectives are to determine:
- The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint).
- The clinical effectiveness of the integrated PFA and mapping system.
- The ability of the novel PFA system to produce durable ablation lesions.
PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance.
Participants will:
- Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia;
- Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure;
- Undergo repeat electrophysiological mapping at 3 months to assess lesion durability;
- Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.
详细描述
Background Atrial fibrillation (AF) is the most common persistent cardiac arrhythmia worldwide, affecting an estimated 1.5-2.0% of the general population. As the population ages, the prevalence of AF continues to rise, imposing a substantial and growing burden on healthcare systems. AF significantly impairs quality of life, elevates stroke risk fivefold, triples the incidence of heart failure, and increases overall mortality.
Initial AF management typically involves pharmacotherapy for rate control or rhythm control. Compared to antiarrhythmic drugs (AADs), catheter ablation offers superior efficacy in reducing AF recurrence, lowering cardiovascular hospitalization rates, and preventing arrhythmia relapse. The cornerstone of catheter ablation is pulmonary vein isolation (PVI), which electrically isolates the pulmonary veins from the left atrium. Current guidelines recommend catheter ablation, primarily PVI, for patients with symptomatic, drug-refractory paroxysmal AF, establishing it as a standard therapy for symptomatic paroxysmal or persistent AF.
Pulsed field ablation (PFA) induces cardiomyocyte death via irreversible electroporation using high-voltage, ultra-rapid electric fields. As a non-thermal energy modality, PFA demonstrates selective myocardial tissue affinity. This characteristic may enable durable lesion formation while sparing adjacent critical structures such as the esophagus, blood vessels, pulmonary veins, and phrenic nerve. Notably, PFA has not been associated with thermal energy complications like atrio-esophageal fistula, phrenic nerve palsy, or pulmonary vein stenosis, suggesting the potential for enhanced efficacy with an improved safety profile.
Recent evidence indicates that integrating three-dimensional (3D) mapping and navigation systems into PFA procedures can reduce radiation exposure while improving procedural accuracy and clinical outcomes.
Therefore, this study aims to evaluate the safety and efficacy of PVI, focal, and linear ablation in patients with persistent AF (PersAF) using a novel shape-adaptive PFA catheter (PFLotus, EnChannel Medical) integrated with a new mapping system (DePolar, EnChannel Medical).
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 18-75 years (inclusive).
- •Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment:
- •A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.
- •Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.
- •3. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).
- •4. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written 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
Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint]
时间窗: Within 3 months post the index ablation
The primary safety endpoint is defined as the incidence of primary adverse events (PAEs) in patients within 3 months after the index ablation. PAEs include: ① Adverse events occurring within 7 days post-ablation; ② Later-occurring events (device- or procedure-related death, atrio-esophageal fistula, pulmonary vein \[PV\] stenosis); ③ Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months post-ablation.
Rate of Acute Procedural Success: Complete Pulmonary Vein Isolation and Bidirectional Block at Targeted Linear Ablation Sites [Primary Efficacy Endpoint]
时间窗: Immediate after the ablation procedure
The primary efficacy endpoint is defined as the rate of acute procedural success immediately after the ablation procedure. Acute procedural success is confirmed when patients meet the following criteria: 1. Complete electrical isolation of all pulmonary veins; 2. Bidirectional block verified at all targeted linear ablation sites (including left atrial posterior wall \[LAPW\], mitral isthmus \[MI\], cavotricuspid isthmus \[CTI\], and superior vena cava \[SVC\]) in those undergoing linear ablation.
次要结局
- Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint](Immediate after the index ablation procedure)
- 1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint](1 year post 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 post the index ablation procedure)
研究者
Hanxiong Liu
Professor
The Third People's Hospital of Chengdu