Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- AF ablation
- 疾病 / 适应症
- Atrial Fibrillation (AF)
- 发起方
- Sir Run Run Shaw Hospital
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation
- 状态
- Enrolling By Invitation
- 最后更新
- 2个月前
概览
简要总结
This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
详细描述
This study evaluates the clinical efficacy and safety of AF catheter ablation procedures in non-fluoroscopic EP labs, compared to fluoroscopy labs. Non-fluoroscopic labs rely on advanced technologies such as three-dimensional electroanatomic mapping system, intracardiac echocardiography (ICE), contact force sensing catheter and/or pulsed field ablation(PFA), etc... Participants are randomized into two groups: 1. Non-Fluoroscopic Lab Group: Ablation procedures will utilize 3D mapping systems. ICE is mandatory for real-time anatomical visualization, and fluoroscopy is employed only in unforeseen procedural challenges to ensure patient safety. 2. Fluoroscopic Lab Group: Procedures are conducted in a fluoroscopic lab using the same tools and mapping system as non-fluoroscopic lab group, with radiation exposure monitored and minimized according to ALARA principles. The primary efficacy endpoint assesses treatment success at 12 months, defined as freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) recurrence for more than 30 seconds, as detected by ECG or 7-day Holter. Safety endpoints include a composite of major adverse events such as stroke, tamponade, myocardial infarction, or phrenic nerve injury within 3 months post-procedure. Secondary endpoints focus on procedural metrics, recurrence during the blanking period, adverse event profiles, and changes in quality-of-life forms using the AF Effect on Quality of Life (AFQT) and the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) instruments. Data collection involves electronic data capture (EDC) systems, with detailed peri-procedural and follow-up evaluations at 3, 6, 9, and 12 months. Each participant undergoes quality-of-life assessments, physical exams, and arrhythmia recurrence monitoring via ECG and 7-day Holter recordings.
研究者
Chenyang Jiang
Director of Atrial Fibrillation Center
Sir Run Run Shaw Hospital
入排标准
入选标准
- •Age: ≥18 years
- •Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
- •Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
- •The patient is able and willing to provide written informed consent.
排除标准
- •Patients with contraindication to anticoagulation
- •Patients with contraindication to right or left sided cardiac catheterization
- •X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
- •Serious known concomitant disease with a life expectancy of \< 1 year
- •MI, CABG, or PCI within the preceding 3 months
- •Left atrial diameter \>55 mm
- •NYHA class III or IV
- •Awaiting cardiac transplantation or other cardiac surgery within 12 months.
- •History of a documented thromboembolic event within the past 6 weeks.
- •Heart or vascular malformation that impedes catheter access or vascular puncture.
研究组 & 干预措施
Non-Fluoroscopic Lab Group
Ablation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization.
干预措施: AF ablation
Non-Fluoroscopic Lab Group
Ablation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization.
干预措施: AF ablation in a non-fluoroscopic EP lab
Fluoroscopic Lab Group
Ablation procedures will be conducted in a fluoroscopic lab. The use of ICE, 3D EP mapping systems, and other tools will follow the same recommendations as in the non-fluoroscopic lab group. Radiation exposure will be closely monitored and minimized in accordance with the ALARA (As Low As Reasonably Achievable) principles when necessary.
干预措施: AF ablation
Fluoroscopic Lab Group
Ablation procedures will be conducted in a fluoroscopic lab. The use of ICE, 3D EP mapping systems, and other tools will follow the same recommendations as in the non-fluoroscopic lab group. Radiation exposure will be closely monitored and minimized in accordance with the ALARA (As Low As Reasonably Achievable) principles when necessary.
干预措施: AF ablation in a fluoroscopic lab
结局指标
主要结局
Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation
时间窗: From enrollment to the end of treatment at 12 months
The primary end point of the study is freedom from any documented atrial arrhythmia, including AF, atrial tachycardia or atrial flutter episodes lasting longer than 30 seconds without antiarrhythmic drugs, for 12 months after the index ablation procedure, excluding a 3-month blanking period. The continuation or reinitiation of class I or class III antiarrhythmic drugs after the 3-month post-ablation blanking period, as well as electric cardioversion or catheter ablation for any atrial arrhythmias, are considered treatment failures for the primary end point.
Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation
时间窗: From enrollment to the end of treatment at 3 months
The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events: * Major vascular complication or major bleeding within the first 7 days post procedure. * Development of a clinically significant pericardial effusion. * Transient ischemic attack. * Stroke. * Myocardial infarction. * Sinus node dysfunction or high-grade atrioventricular block within 30 days. * Severe pulmonary vein stenosis. * Atrial-esophageal fistula, or phrenic nerve injury within 3 months. * Death.
次要结局
- Acute Success of the Procedure(From the start to the completion of the procedure.)
- Proportion of Intra-Procedural Conversion to Using X-ray(From the start to the completion of the procedure.)
- Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation(from the time of ablation to 90 days post-ablation.)
- Incidence of Peri-Procedural Complications(From the start of the procedure to 7 days post-ablation.)
- Total Procedure Duration(During the procedure.)
- Ablation Time(During the procedure.)
- Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument(From enrollment to the end of treatment at 12 months)
- Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument(From enrollment to the end of treatment at 12 months)