Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead: The Dx-AF Study
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 9
- 主要终点
- Atrial Fibrillation or atrial flutter lasting at least 6 minutes
研究概览
简要总结
This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
详细描述
Recipients of implantable defibrillators (ICD) are at high risk of developing both AF and stroke, given the presence of multiple cardiovascular risk factors. Oral anticoagulation can prevent most strokes in patients with AF; provided that AF is recognized before a stroke occurs. Up to about 40% of incident AF may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection.
DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will be randomized to a VDD ICD (experimental group) or single chamber ICD (control group).
The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic or non-ischemic cardiomyopathy,
- •LVEF<50%, scheduled for primary or secondary prevention ICD
- •Treating physicians feel that the use of single chamber ICD is appropriate
- •No ECG-documented history of AF or flutter
- •Age > 50 years
排除标准
- •Known AF or flutter
- •Current use of class I or III anti-arrhythmic medications
- •Participants unwilling to attend study follow-up visits, considered unreliable for compliance or with an anticipated life expectancy less than 3 years
研究组 & 干预措施
VDD ICD
VDD ICD - A single-lead ICD system with the ability to sense atrial rhythm from the floating electrode (a VDD-ICD known as the DX) - Experimental group
干预措施: VDD ICD (experimental group) (Device)
VVI ICD
VVI ICD - Single chamber ICD system - Control group
干预措施: Single chamber VVI ICD (control group) (Device)
结局指标
主要结局
Atrial Fibrillation or atrial flutter lasting at least 6 minutes
时间窗: During the entire time of follow up - 3 years
Atrial Fibrillation or atrial flutter lasting at least 6 minutes detected by the ICD, ECG, Holter monitor or telemetry.
次要结局
- New pericardial effusion(60 days)
- Cardiac tamponade(60 days)
- Need for any ICD lead repositioning or replacement(60 days)
- Pneumothorax(60 days)
- Procedure-related death or wound infection(60 days)