Bariatric Atrial Restoration of Sinus Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time to first recurrence of AF following a 3-month blanking period after the ablation.
研究概览
简要总结
The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.
详细描述
This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obesity.
Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits Group A will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in Group B will be baseline, clinical visit prior AF ablation, and at 3, 6, and 12 months post AF ablation. At each post ablation visit the following data will be collected:
AT/AF recurrence determined by ambulatory monitoring, clinic visit, or hospitalization; Physical Exam (weight, height, vitals); 12 lead ECG; Medication Regimen; AF Symptom Severity Scale (AFSS); Quality of Life (AFEQT); Laboratory Testing; and Adverse Events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic agent
- •EF > 40%
- •BMI > 40 or BMI > 35 and at least one of the following co-morbidities:
- •Type 2 Diabetes Mellitus (by American Diabetes Association diagnostic criteria).
- •Systolic blood pressure of 130 mmHg and/or diastolic blood pressure 80 mmHg or higher despite medical treatment with maximal doses of three antihypertensive medications).
- •Refractory hyperlipidemia (acceptable levels of lipids unachievable with diet and maximum doses of lipid lowering medications).
- •Obesity-induced cardiomyopathy.
- •Clinically significant obstructive sleep apnea.
- •Obesity-related hypoventilation.
- •Pseudotumor cerebri (documented idiopathic intracerebral hypertension).
- •Severe arthropathy of spine and/or weight-bearing joints (when obesity prohibits appropriate surgical management of joint dysfunction treatable but for the obesity).
- •Hepatic steatosis without evidence of active inflammation.
- •Hypertriglyceridemia
- •Polycystic Ovary Syndrome (PCOS)
- •Coronary Artery Disease (CAD)
排除标准
- •Prior bariatric surgery
- •Prior AF catheter ablation
- •BMI > 65 kg/m2
- •Contraindication to bariatric surgery or AF ablation
- •Contraindication to therapeutic anticoagulation
- •Sustained AF lasting more than 3 years
- •Left atrial diameter of greater than or equal to 60 mm or LA volume greater than or equal to 60 ml/m2
结局指标
主要结局
Time to first recurrence of AF following a 3-month blanking period after the ablation.
时间窗: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
The primary outcome measure will be time to first recurrence of any atrial arrhythmia including AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds and occurring more than 3 months after AF ablation, without the use of antiarrhythmic medications. An episode of AF or atrial tachycardia will be considered part of the primary outcome analysis if it lasts longer than 30 seconds and is documented by any form of electrocardiographic monitoring, regardless of symptoms. A repeat catheter ablation procedure at any time will constitute a recurrence for the outcome analysis.
次要结局
- Change from Baseline in AF Quality of Life Score(Baseline (Initial), 12 months)
- Change in AF Burden off anti-arrhythmic agents monitor(Baseline (Initial), 12 months))
- Change from Baseline in AF symptom severity(Baseline (Initial), 12 months)
研究者
Paul Wang
Director, Stanford Electrophysiology and Arrhythmia Service
Stanford University