NCT02131337已完成不适用
Efficacy Study on Atrial Fibrillation Percutaneous Catheter Ablation With Contact Force Support 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Number of pulmonary vein isolation (PVI) gaps per vein
研究概览
简要总结
EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.
详细描述
EFFICAS II is a single-arm, prospective study, where the operator will have access to contact force information and use it actively to optimize the ablation result and adapting power if necessary. The endpoint will correlate contact force parameters initially applied in PV and 3 months PV isolation status, and compare results to those of EFFICAS I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age but not over 75 years of age
- •Patient has at least one episode of sustained (>30s) paroxysmal atrial fibrillation documented by 12-lead ECG, holter monitor, transtelephonic event monitor, telemetry strip, or Pacemaker respectively implantable cardioverter defibrillator (ICD) within 12 months prior to enrolment
- •Patient has symptomatic paroxysmal atrial fibrillation (PAF) refractory or intolerant to at least one Class I-IV anti-arrhythmic drug
- •Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up scheme
- •Patient provides written informed consent prior to enrolment in the study
排除标准
- •Not adhering to inclusion criteria
- •Active systemic infection
- •Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
- •Reversible causes of Arrhythmia including thyroid disorders, acute alcohol intoxication, recent (less than 3 months) major surgical procedures
- •Patient has a left atrial diameter > 5.0 cm
- •Patient has persistent or long-standing persistent atrial fibrillation (AF)
- •Left ventricular ejection fraction < 35%
- •New York Heart Association (NYHA) class III or IV
- •Previous left atrial heart ablation procedure, either surgical or catheter ablation
- •Patient has an intracardiac mural thrombus or has had a ventriculotomy or atriotomy
- •Patient has moderate or severe structural heart disease as demonstrated by transthoracic or trans-esophageal echocardiogram of all four chambers of the heart (ventricular dysfunction or valve disease)
- •Tricuspid or mitral valve replacement or repair
- •If female of childbearing potential - pregnant or breastfeeding
- •Patient has a bleeding diathesis or suspected pro-coagulant state
- •Patient has contraindication to long-term antithromboembolic therapy (e. g. acetylsalicylic acid, heparin, warfarin)
- •Presence of condition that precludes appropriate vascular access
- •Heart disease in which corrective surgery is anticipated within 6 months
- •Renal failure requiring dialysis
- •Patient has a known sensitivity to contrast media (if needed during the procedure) that cannot adequately be controlled with pre-medication (or totally excluded)
- •Patient has other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
- •Patient is currently participating in another clinical trial
- •Patient is unlikely to survive over one year
研究组 & 干预措施
Contact force lesions
Other
干预措施: Electrophysiology study (Other)
结局指标
主要结局
Number of pulmonary vein isolation (PVI) gaps per vein
时间窗: 3 months
Number of gaps in EFFICAS 2 is lower than in EFFICAS 1 and Contact force in EFFICAS 2 has reduced variability than in EFFICAS 1. Confounding parameters such as lesion continuity will be determined for the remaining gaps in EFFICAS 2.
次要结局
未报告次要终点
研究者
研究点 (3)
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