NL-OMON50970招募中4 期
The POWER-PLUS study - Very high power ablation in patients with atrial fibrillation scheduled for a first pulmonary vein isolation - The POWER-PLUS study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age older than 18 years
- •Being scheduled for a first PVI only for paroxysmal AF (self-terminating or
- •<7days) or persistent AF (persistent AF is defined as having an AF episode
- •>7d); (patients with paroxysmal AF or short-standing persistent AF presenting
- •with flutter, who are in need of a CTI ablation, are allowed to participate in
- •this trial)
- •Patients willing to sign informed consent
排除标准
- •Patients with long-standing persistent AF (long-standing persistent AF is
- •defined as having an AF episode >1yr)
- •Previous ablation for AF
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or
- •non-cardiac cause
- •Left atrial thrombus. LAA thrombus can be determined by preprocedural
- •imaging: intracardiac echo, CT, TEE or MRI.
- •Abnormal echocardiography defined by at least one of the following criteria
- •o Left ventricular ejection fraction <35%
- •o LA antero-posterior diameter >50 mm (parasternal long axis view, PLAX), if
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Coronary PTCA/stenting within the previous 90 days or myocardial infarction
- •within the previous 60 days.
- •Documented history of a thromboembolic event within the previous 90 days.
- •Women who are pregnant or who plan to become pregnant during the study.
- •Acute illness or active infection at time of index procedure
- •Advanced renal insufficiency
- •Unstable angina
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Presence of a condition that precludes vascular access.
- •Unwilling or unable to provide informed consent.
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