Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
研究概览
简要总结
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death
详细描述
While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing.
This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (AHA/ACC) guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention.
- •The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.
排除标准
- •Pregnant women
- •Age <18 years old
- •Inability to provide consent
- •On a heart transplant waiting list
- •Life expectancy <1 year
- •Indication for pacing
- •Atrioventricular (AV) node ablation
- •Permanent atrial fibrillation or atrial flutter
- •Indication for cardiac resynchronization
- •Preexisting, separate pacemaker pulse generator that won't be explanted
- •Intra-aortic balloon pump or other device
- •Inotropic drug (not digitalis) necessary for hemodynamic support
- •Chronic serious bacterial infection
- •Inability to receive pectoral non-thoracotomy lead ICD
- •Inability to program device according to protocol
- •History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)
结局指标
主要结局
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
时间窗: Baseline to 12 months after ICD implantation
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
次要结局
- Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes(Baseline to 12 Months)
- Number of Appropriate Shocks by ICD(Baseline to 12 Months)
- Total Cost of ICD Implantation Procedure(Baseline)
- Number of Subjects With Newly Detected Atrial Tachyarrhythmias(Baseline to 12 months after ICD implantation)
- Atrial Fibrillation (AF) Burden(Implantation through 1 year)