Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
研究概览
简要总结
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
详细描述
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
- •Subject has severe heart failure (NYHA Class III or IV)
- •Subject has experienced at least one heart failure event within six months prior to enrollment
- •Subject continues to have heart failure symptoms despite receiving optimal medical therapy
- •Schedule for implant of a PARADYM CRT-D (Model 8770)
- •Subject has signed and dated an informed consent form
排除标准
- •Any contraindication for standard cardiac pacing
- •Any contraindication for ICD therapy
- •Abdominal implantation site
- •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 (intravenous 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 or HIPAA
- •Unavailability for scheduled follow-up at the implanting center
- •Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
- •Under guardianship
- •Age of less than 18 years
- •Pregnancy
结局指标
主要结局
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
时间窗: Thirteen months
Mean number of false positives per patient per year.
时间窗: Thirteen Months
次要结局
未报告次要终点