Waiting on Atrial fibrillation Intervention Therapy (WAIT) Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary variable: Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds as detected by continuous monitoring via implantable loop recorder at 12 months post-ablation. Events within the initial 3-month blanking period will not be included.
研究概览
简要总结
The primary objective of this trial is to evaluate whether treatment with a GLP-1 receptor agonist (semaglutide) in overweight or obese patients scheduled for first-time catheter ablation for atrial fibrillation can improve arrhythmia-free survival at 12 months post-ablation compared to standard of care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent prior to participation.
- •Age ≥18 years
- •Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.
- •Body Mass Index (BMI) ≥30 kg/m² (obesity) OR BMI ≥27 kg/m² (overweight) with one or more of the comorbidities listed in the protocol under section 6.1, inclusion criteria nr.
- •For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).
排除标准
- •Morbid obesity (BMI >40 kg/m²).
- •History of pancreatitis or recurrent hypoglycemia.
- •Uncontrolled diabetic retinopathy
- •Severe renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m² or in dialysis)
- •Severe hepatic failure (decompensated liver disease Child–Pugh class C)
- •Severe cardiac failure (NYHA class IV)
- •Diabetes type 1
- •Life expectancy <12 months.
- •Inability to self-administer the investigational medicinal product.
- •Prior catheter ablation procedure for atrial fibrillation.
- •Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.
- •Participation in another interventional clinical trial within the past 30 days.
- •Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.
- •Current use of DPP-IV inhibitors
- •Known intolerance or contraindication to semaglutide.
结局指标
主要结局
Primary variable: Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds as detected by continuous monitoring via implantable loop recorder at 12 months post-ablation. Events within the initial 3-month blanking period will not be included.
Primary variable: Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds as detected by continuous monitoring via implantable loop recorder at 12 months post-ablation. Events within the initial 3-month blanking period will not be included.
次要结局
未报告次要终点
研究者
Emma Svennberg
Scientific
Karolinska University Hospital