'CLOSE'-Guided Pulmonary Vein Isolation as Cure for Paroxysmal Atrial Fibrillation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
研究概览
简要总结
Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation ('CLOSE to CURE' study)
Design: This is a prospective, observational, single-center, unblinded, clinical 3-year study.
Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new approach to obtain single-procedure durable PVI, has been shown to virtually eliminate recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring.
Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.
Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study.
Clinical Sites: 1 site.
Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask the patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012 European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal 2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation (Calkins et al, Heart Rhythm 2012).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic paroxysmal AF (history of self-terminating AF within 7 days or history of self-terminating AF with 1 or more cardioversions within 48 hours after onset), meeting following criteria at the out-patient clinic:
- •patient has at least 3 AF episodes in the last 3 months prior to the visit
- •AF episodes are symptomatic, and patient is drug-resistant (at least one class IC or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,...)
- •no advanced structural heart disease
- •patient has a CHA2DS2-VASc score of 0, 1, 2, 3 or 4
- •Signed Patient Informed Consent Form.
- •Age 18 years or older.
- •Able and willing to comply with all follow-up testing and requirements.
排除标准
- •Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
- •Previous ablation for AF
- •LA antero-posterior diameter > 50 mm (parasternal long axis view , PLAX)
- •LVEF < 35% (ejection fraction)
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Coronary artery bypass grafting (CABG) procedure within the last three months
- •Awaiting cardiac transplantation or other cardiac surgery
- •Documented left atrial thrombus on imaging
- •Diagnosed atrial myxoma
- •Women who are pregnant or breastfeeding
- •Acute illness or active systemic infection or sepsis
- •Unstable angina
- •Uncontrolled heart failure
- •Myocardial infarction within the previous two months
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- •Life expectancy less than 12 months
- •Enrollment in any other study evaluating another device or drug
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
结局指标
主要结局
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI
时间窗: Continuous monitoring (24 hours loop recording)
Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure
时间窗: Continuous monitoring (24 hours loop recording)
次要结局
- Evaluating PV re-connection at redo procedure assessed by Lasso catheter(3 months to 3 years)
- Incidence of adverse events related to ablation(Baseline to 3 years)
- Freedom from stroke/transient ischemic attack (TIA)(Baseline to 3 years)
- Efficacy of CLOSE protocol ablation assessed by multiple-procedure freedom from ATA(1 month to 3 years)
- Health economics and outcomes research assessed by quality of life using Short Form (SF-36v2) Health Survey(Recruitment to 3 years)
- Health economics and outcomes research assessed by number of hospitalization(Recruitment to 3 years)
- Evaluating progression of scarring at redo procedure assessed by voltage mapping(3 months to 3 years)
- Efficacy of CLOSE protocol ablation assessed by single-procedure freedom from documented atrial tachyarrhythmias (ATA)(1 month to 3 years)
- Efficacy of CLOSE protocol ablation assessed by incidence of repeat ablation procedures(1 month to 3 years)
- Health economics and outcomes research assessed by quality of life using Symptomatic Questionnaire V3(Recruitment to 3 years)
研究者
Prof. Dr. Mattias Duytschaever
Professor Doctor
AZ Sint-Jan AV