NCT02167789已完成3 期
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 520
- 试验地点
- 95
- 主要终点
- Number of HF related events
研究概览
简要总结
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
详细描述
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- •Severe HF (NYHA Class III or IV) at the time of enrollment
- •At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
- •Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
- •Scheduled for implant of a PARADYM 8770
- •Signed and dated informed consent
排除标准
- •Any contraindication for standard cardiac pacing
- •Any contraindication for ICD therapy
- •Abdominal implantation side
- •Hypertrophic or obstructive cardiomyopathy
- •Acute myocarditis
- •Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
- •Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
- •Correctable valvular disease that is the primary cause of heart failure
- •Mechanical tricuspid valve
- •Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
- •Heart transplant recipient
- •Renal insufficiency requiring dialysis
- •Already included in another clinical study
- •Life expectancy less than 12 months
- •Inability to understand the purpose of the study or refusal to cooperate
- •Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Unavailability for scheduled follow-up at the implanting center
- •Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
- •Under guardianship
- •Age of less than 18 years
- •Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
结局指标
主要结局
Number of HF related events
时间窗: 13 months
次要结局
- Co morbidities(13 months)
研究者
研究点 (95)
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