NCT01233661撤回不适用
Short Atrioventricular Delay Pacing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- serum biomarker concentrations
研究概览
简要总结
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
- •Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
- •Ability to provide informed consent
排除标准
- •Age <18 years or >80 years
- •Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
- •Recent (within 12 months) left ventricular ejection fraction <50%
- •Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
- •Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
- •History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy).
- •Significant chronic systemic inflammatory or neoplastic disease
- •Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR >1.4 without oral anticoagulant use, albumin < 3.0 mg/dL) or abnormal clearance function (total bilirubin >2.0).
- •Uncorrected thyroid abnormalities
结局指标
主要结局
serum biomarker concentrations
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
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