NL-OMON54958招募中不适用
CRyoballoon Ablation versus mediCal thErapy in patients with Heart Failure and atrial fibrillation: A multicenter randomized clinical trial, the RACE-8-HF trial - RACE-8-HF trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
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
- •- Patients aged 18-80;
- •- HF with ejection fraction <50%, as assessed by recent (<6 months)
- •echocardiography,
- •cardiovascular magnetic resonance imaging (CMR) or other cardiac imaging;
- •- Documented AF;
- •- Eligible for both treatment arms;
- •- Signed and dated informed consent prior to admission to the trial.
排除标准
- •- End-stage heart failure: NYHA class IV, patients on waiting list for cardiac
- •transplant and/or left ventricular assist device;
- •- Long-standing persistent AF (> 1 year uninterrupted AF) or permanent AF;
- •- Asymptomatic patients;
- •- Previous pulmonary vein isolation or surgical ablation;
- •- Impaired renal function, defined as estimated glomerular filtration rate
- •(eGFR) <=25 ml/min/1.73m2;
- •- Recent (<90 days) acute coronary syndrome, cardiac intervention, or
- •stroke/transient ischemic attack (TIA);
- •- Planned or expected cardiac surgery in the following year;
- •- Active infectious disease or malignancy;
- •- Women who are pregnant or planning to become pregnant during the trial;
- •- Known allergy for contrast, contraindication for cryoballoon ablation, or
- •other conditions that may prevent subjects from adhering to the trial protocol,
- •in the opinion of the investigator.
研究者
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