Three-Dimensional Guidance for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Study on Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 主要终点
- 12-Month Postoperative Treatment Success Rate
研究概览
简要总结
Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure. In China, AF affects approximately 20 million adults, and its prevalence is expected to rise due to aging [1, 2]. Catheter ablation has become a first-line treatment for AF, with pulsed field ablation (PFA) gaining attention due to its tissue selectivity and non-thermal ablation properties [3-8]. PFA uses high-voltage electric fields to create cell membrane perforations, leading to permanent tissue damage and effective arrhythmia treatment [6-8].
Recent studies have shown that PFA is highly effective and safe. For example, the EU-PORIA study reported a 99.96% pulmonary vein isolation (PVI) rate with a 3.6% complication rate [9, 10], while the ADVENT study demonstrated similar efficacy to thermal ablation but with shorter procedure times [12]. However, current PFA systems often lack integration with 3D mapping systems, limiting their application in complex cases and increasing reliance on fluoroscopy [13, 14].
In China, domestic PFA technology is rapidly evolving, with a focus on expanding indications and integrating 3D techniques [19, 20]. The investigators have conducted preliminary studies on the feasibility and safety of domestic PFA in persistent AF treatment [21]. To further advance PFA, larger-scale clinical studies are needed to optimize procedural workflows and reduce complications.
This study aims to enroll 430 participants through a single-center, single-arm approach. By following up for one year, the investigators will optimize the PFA procedure under 3D guidance to enhance success rates and safety. This will support the clinical promotion of PFA technology and provide valuable data for the development of domestic PFA devices.
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
- •Aged 18 years or older, regardless of gender.
- •Patients with paroxysmal atrial fibrillation scheduled for catheter ablation.
- •Willing and able to comply with all follow-up requirements and agree to participate in this study.
排除标准
- •Previous left atrial catheter ablation.
- •Left ventricular ejection fraction (LVEF) < 35%.
- •Left atrial diameter (assessed by echocardiography) > 55 mm.
- •Presence of definite thrombus in the left atrium or any other cardiac chamber detected before surgery.
- •Patients with New York Heart Association (NYHA) functional class III-IV heart failure.
- •Patients with second-degree (Type II) or third-degree atrioventricular block.
- •Significant congenital heart defects (e.g., atrial septal defect or severe pulmonary vein stenosis, but not including patent foramen ovale).
- •Patients with prosthetic heart valves.
- •Patients with implanted cardiac pacemakers or implantable cardioverter-defibrillators (ICDs).
- •Patients diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
- •Patients with known symptomatic carotid artery stenosis before surgery.
- •Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Patients with systemic active infections.
- •Patients with significant bleeding tendencies or those undergoing hemodialysis for renal failure.
- •Patients who have experienced a myocardial infarction or undergone any cardiac intervention/open-heart surgery within the past 3 months.
- •Patients who have had a stroke or transient ischemic attack within the past 6 months.
- •Patients with significant contraindications to interventional procedures, as determined by the investigator, who are unable to undergo ablation surgery.
- •Pregnant or breastfeeding women, or those planning to conceive during the study period.
- •Patients who have participated in other drug or medical device clinical trials within the past 3 months.
- •Patients whom the investigator deems unsuitable for participation in this clinical trial.
结局指标
主要结局
12-Month Postoperative Treatment Success Rate
时间窗: 12 months
Definition of 12-Month Postoperative Treatment Success: No recurrence of atrial arrhythmias (atrial fibrillation, atrial tachycardia, or unexplained atrial flutter) lasting ≥30 seconds from 3 months to 12 months postoperatively, and no occurrence of any of the following failure modes: immediate procedural failure, repeat ablation failure (more than 1 repeat ablation during the blanking period, or any repeat ablation outside the blanking period), antiarrhythmic drug (AAD) failure (use of new Class I/III AADs for treatment of atrial fibrillation, atrial tachycardia, or unexplained atrial flutter, or increased dosage of previously failed Class I/III AADs), persistent atrial fibrillation/atrial tachycardia/atrial flutter documented by standard 12-lead ECG, or failure of electrical cardioversion. Calculation: 12-Month Postoperative Treatment Success Rate = (Number of patients with treatment success at 12 months / Total number of patients completing 12-month follow-up) × 100%
次要结局
- Immediate Procedural Success Rate(immediately after procedure)
- Success Rate of No Recurrence of Atrial Arrhythmias (≥30 seconds) Without Class I/III AADs from 3 Months to 12 Months Postoperatively(12 months)