Rhythm ID Going Head-to-head Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,962
- 试验地点
- 1
- 主要终点
- Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
研究概览
简要总结
RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.
详细描述
RIGHT will compare the incidence of Ventricular Tachycardia/Fibrillation (VT/VF) therapies delivered for Supraventricular Tachycardia (SVT) episodes using VITALITY 2 devices with Rhythm ID™ to that of ICDs employing other rhythm discrimination algorithms. Appropriateness of therapies will be assessed after independent adjudication of all VT/VF events leading to therapy. Comparisons will be made between device manufacturers across patient populations receiving either a dual- or single-chamber device.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet current indications for an ICD
- •Patients who sign and date a Patient Informed Consent form prior to the implant visit
- •Patients who remain in the clinical care of the enrolling physician in approved centers
- •Patients who are able to tolerate ICD programming as specifically prescribed in the study protocol
排除标准
- •Patients who are in third degree heart block
- •Patients whose life expectancy is less than 12 months
- •Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study
- •Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
- •Patients who are younger than 18 years of age
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
- •Patients who are pregnant or plan to become pregnant during the study
研究组 & 干预措施
Implantable Cardioverter Defibrillator - Boston Scientific
VITALITY 2 ICD
干预措施: VITALITY 2 Implantable Cardioverter Defibrillator (Device)
Implantable Cardioverter Defibrillator - Medtronic
Selected Medtronic family ICD
干预措施: Medtronic Implantable Cardioverter Defibrillator (Device)
结局指标
主要结局
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
时间窗: From date of pre-discharge until a minimum of 12 months follow-up until study closure
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
次要结局
- Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)(Time of event)
- Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)(Time of event)
- Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode(Time of event)