Extended Ablation Versus Pulmonary Vein Isolation to Treat 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
- 450
- 主要终点
- Freedom from AF, AT and AFL
研究概览
简要总结
The aim is to determine the effect of extended ablation (pre-specified linear PF/RF lesion set) in addition to PVI in symptomatic persistent AF patients on AF/AT/AFL recurrence. The study is designed as multicenter, randomized trial. Eligible patients are patients with persistent AF (but not long-standing persistent AF) planned for a first-ever AF ablation procedure. Patients will be randomly assigned 1:1 either to: i) PVI-only, or ii) PVI-plus arms. Patients in both groups will undergo catheter ablation using an ablation system capable of performing PF and RF ablation (Sphere-9, Affera, Medtronic). Patients randomized to the PVI-only arm will undergo only PVI. Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA). The primary endpoint will be freedom from recurrent AF/AT/AFL, assessed as time-to-first recurrence in the period of 12 months after randomization (post 2-month blanking period). Secondary clinical endpoints will be 1) 12-month differences in AF/AT/AFL burden, 2) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 3) Quality of life according to the AFEQT questionnaire score at 12 months, 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.
详细描述
BACKGROUND The cornerstone of catheter ablation for AF is pulmonary vein (PV) isolation (PVI). PVI alone is highly effective in patients with paroxysmal AF; however, its efficacy is lower in patients with non-paroxysmal AF (persistent and long-standing persistent). For this reason, additional ablation strategies have been developed and investigated in patients with non-paroxysmal AF. However, results from randomized catheter-based studies comparing PVI alone with extended ablation strategies combining PVI with additional linear lesions have been inconsistent. While some studies showed no improvement in sinus rhythm (SR) maintenance with the addition of linear lesions compared with PVI alone, other studies demonstrated superiority of an extensive ablation approach, including linear lesions over PVI alone. A key determinant of success in these studies is the completeness of the ablation lesion set. . In studies using radiofrequency (RF) energy alone, such as the STAR AF II trial, all planned linear ablation lesions were completed in only 74% of patients during the procedure. Moreover, in the CAPLA study, comparing PVI alone with PVI combined with adjunctive left atrial (LA) posterior wall isolation using roof and inferior lines, posterior wall reconnections were present in 75% of patients. However, the results of older catheter ablation studies that relied solely on RF energy cannot be directly extrapolated to contemporary procedures performed using PF energy or combined PF/RF systems that also enable simultaneous endocardial mapping and thus reliable identification of conduction gaps and completion of ablation lesions. The markedly higher efficacy of these newer energy modalities and their combinations raises the question of whether highly effective comprehensive endocardial ablation, including linear lesions, will be associated with superior sinus rhythm maintenance compared with PVI alone.
The aim of this study is therefore to compare PVI-alone with an extended ablation strategy (PVI plus linear lesions) in patients with persistent AF, using a technology that enables ablation with both PF and RF energy and 3D mapping.
STUDY DESIGN Prospective, randomized controlled trial that will be conducted at 4 sites in the Czechia.
STUDY POPULATION The study focuses on patients with persistent AF as defined in recent ESC guidelines (i.e., with ≥2 AF episodes; ≥1 episode with a duration of >7 days) who are referred the catheter ablation in accordance with the indication criteria outlined in these guidelines.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Technicians and physicians responsible for Holter monitoring analysis will be fully blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic persistent AF
- •≥1 episode of persistent AF in the last 12 months
- •signed informed consent
排除标准
- •first-manifested AF, paroxysmal AF, long-standing persistent AF, permanent AF
- •SR on admission without Class I/III AADs
- •AF of secondary cause (e.g. hyperthyroidism)
- •any previous LA ablation
- •severe valvular disease (mitral valve insufficiency ≥3+, moderate or severe aortic stenosis) or history of valvular surgery or intervention
- •left ventricular ejection fraction ≤40%
- •pulmonary hypertension (estimated systolic pulmonary artery pressure ≥40 mm Hg)
- •symptomatic coronary artery disease
- •pregnancy
- •LA anteroposterior diameter ≥55 mm
- •body mass index ≥40 kg/m2
- •age ≥80 years
- •chronic kidney disease stage 3b or higher
- •contraindication to anticoagulation
- •general contraindications of catheter ablation
- •life expectancy <2 years due to other comorbidities
研究组 & 干预措施
PVI-plus group
Patients allocated in the PVI-plus arm will undergo comprehensive ablation consisting of pulmonary vein isolation, roof line, inferior line, mitral ishtmus line, horizontal line in the left atrium, intercaval line, and cavotricuspid line in the right atrium.
干预措施: PVI-plus (Procedure)
PVI-only group
Patients allocated in the PVI-only arm will undergo pulmonary vein isolation without any additional ablation lesions.
干预措施: PVI-only (Procedure)
结局指标
主要结局
Freedom from AF, AT and AFL
时间窗: 12 months
Freedom from recurrent atrial fibrillation, atrial tachycardia, or atrial flutter, assessed as time-to-first recurrence. An episode of atrial fibrillation, atrial tachycardia or atrial flutter is defined as either (1) a recording demonstrating at least 30 seconds of continuous interpretable signal during Holter monitoring performed at 3, 6, 9, or 12 months, or (2) a 12-lead ECG demonstrating the arrhythmia throughout the entire tracing, with at least 10 seconds of continuous interpretable signal during scheduled or emergency visits.
次要结局
- AF/ AT/AFL burden(12 months)
- AF-related clinical outcomes(36 months)
- Quality of life(12 months)
- MACE(36 months)