NCT01466842Unknown不适用
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months
研究概览
简要总结
The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65
- •At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
- •Never taken antiarrhythmic drugs or at most a pill in the pocket approach
- •Willingness, ability and commitment to participate in baseline and follow-up evaluations
排除标准
- •Paroxysmal AF for more than three years
- •An episode of atrial fibrillation that lasted more than seven days within the past six months
- •Persistent/permanent atrial fibrillation
- •Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
- •Documented atrial flutter
- •Structural heart disease of clinical significance including:
- •Cardiac surgery within six months of screening
- •Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
- •Unstable angina
- •Myocardial infarction within six months of screening
- •Surgically corrected atrial septal defect with a patch or closure device
- •LA size > 40mm
- •Any prior ablation of the pulmonary veins
- •Enrollment in any other ongoing protocol
- •Untreatable allergy to contrast media
- •Pregnancy
- •Any contraindication to cardiac catheterization
- •Prosthetic mitral heart valve
- •Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
- •Contraindication to coumadin or heparin
- •History of pulmonary embolus or stroke within one year of screening
- •Acute pulmonary edema
- •Atrial clot on TEE regardless of the patient's anticoagulation medication status
结局指标
主要结局
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months
时间窗: 6 months
次要结局
- any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up(3 years)
- comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires(3, 6, 12, 24 and 36 months)
- number of track complications, both acute (during the procedure) and chronic throughout the trial(3 years)
- hospitalization rate during a two and a half year follow-up following the initial six months follow-up(3 years)
研究者
研究点 (2)
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