DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 主要终点
- CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
研究概览
简要总结
The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non selected population with conventional indication of ICD implantation.
详细描述
Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive rationale solution, although controversy remains if the costs and complexity of the implants offer a real clinical advantage.
The DATAS is a, prospective, multicentre, randomized, open labelled study, with three arms (two of them cross-over and the third parallels the other two)
The primary objective of this trial is to determine whether use of Dual Chamber ICD (DDED-DDDR NASPE/BPEG Defibrillator/Pacemaker Codes) results in a significant decrease in the number of primary end points.
The primary end point is a composite comprising four so-denominated "Clinically Significant Adverse Events (CSAE)":
- all-cause mortality
- invasive intervention, hospitalization (>24 h) or prolongation of hospitalization due to cardiovascular cause
- inappropriate shocks (two or more episodes with inappropriate shocks)
- sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).
排除标准
- •Permanent atrial fibrillation
- •Patients without structural heart disease
- •Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block ).
- •Patient with previous system implanted (ICD or pacemaker).
- •Patients with biventricular stimulation or re-synchronization.
- •Patient has a mechanical right heart valve.
- •Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation.
- •Patient is unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent.
- •Patient is or will be inaccessible for follow-up at the study center.
- •Patients who are enrolled or planning to enroll in other clinical trials during the clinical study.
结局指标
主要结局
CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
时间窗: 17 months
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
次要结局
- Number of Each of the Components of the CSAE(17 months)