Characterization and Elimination of Mother Rotors - A Mechanism-targeted Approach for Catheter Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- freedom from symptomatic AF, atrial tachycardia, and atrial flutter
研究概览
简要总结
Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained by localized sources called "mother rotors" which exhibit persistent, fast, and well organized activity during AF and play an important role in the generation and maintenance of the fibrillatory activity. In this study, investigators aim to identify the electrophysiological characteristics of mother rotors during atrial fibrillation in patients with paroxysmal and persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.
详细描述
The present study is designed as a prospective, single-centre, randomized, single-blind, controlled, 2-arm parallel group trial.
The study will consist of:
i) a two-month screening period; ii) randomization and treatment phase; iii) a follow-up phase lasting up to 24 months. Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure will be screened. It is expected that approximately 260 patients will be screened in order to have 234 patients fulfilling inclusion criteria at the end of the screening period. The sample will include 154 patients with paroxysmal AF and 80 patients with persistent AF. Paroxysmal and persistent AF will be defined according to current ESC guidelines.
Patients fulfilling selection criteria, will be informed of the study and asked for participation. The study requirements, including required testing, will be discussed with the subject. A signed Informed Consent Form for study participation must be obtained prior to any study-related procedure. Patients will be given a daily diary for recording AF-related signs and symptoms and instructed to bring it back at the inclusion visit.
Eligible patients will be randomised using a web-based randomization system embedded in the electronic CRF (e-CRF).
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure
- •Age between 18 and 85 years
- •Ability to provide informed consent for study participation and be willing and able to comply with study evaluations and follow-up schedule
- •AF burden equal to or greater than 24 hours in the screening period before enrollment
排除标准
- •Previous AF ablation
- •Secondary AF
- •Hyperthyroidism
- •Left ventricular ejection fraction <30%
- •NYHA functional class IV
- •Left atrial area > 35 cm2
- •Uncorrected severe valvular heart disease
- •Contraindication to anticoagulation
- •Presence of left atrial thrombus
- •Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass
- •Thoracic surgery for congenital, valvular or aortic disease
- •History of cerebrovascular accidents
- •Pregnancy
- •Significant comorbidities such as cancer, severe renal insufficiency requiring hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less than 1 year.
研究组 & 干预措施
standard circumferential pulmonary vein isolation (CPVI)
standard circumferential pulmonary vein isolation by radiofrequenvy ablation
干预措施: standard circumferential pulmonary vein isolation by radiofrequency ablation catheter (Procedure)
CPVI + Rotor
standard circumferential pulmonary vein isolation + rotors' identification and ablation'
干预措施: CPVI + rotors' identification and ablation (Procedure)
结局指标
主要结局
freedom from symptomatic AF, atrial tachycardia, and atrial flutter
时间窗: from the end of the 3 months blanking period to 12 months following the ablation proce
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
次要结局
- characteristics of Rotors electrograms(at time of pre-ablation electrophysiological mapping)
- Freedom from asymptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug(from the end of the 3 months blanking period to 12 months following the ablation procedure)
- One year clinical/partial success rate(12 months following the ablation procedure)
- Number of Rotors electrograms(at time of pre-ablation electrophysiological mapping)
- anatomical locations of Rotors electrograms(at time of pre-ablation electrophysiological mapping)