Diagnostic Outcome Trial in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 335
- 试验地点
- 2
- 主要终点
- Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
研究概览
简要总结
The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
详细描述
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no
排除标准
- •, are eligible for this study.
- •Exclusion Criteria:
- •Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
- •Subject received a coronary artery bypass graft or valve surgery in last 90 days
- •Subject with a myocardial infarction (MI) in the last 40 days.
- •Subject's life expectancy is less than one year in the opinion of the physician
- •Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by physician and documented in medical records
- •Subject is listed for valve replacement/valve repair
- •Subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records
- •Subject with serum creatinine ≥ 2.5 mg/dL measured within 14 days prior to enrolment
- •Subject on chronic renal dialysis
- •Subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for HF
- •Subject has complex and uncorrected Congenital Heart Disease
研究组 & 干预措施
Access Arm
HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report
干预措施: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) (Device)
Control arm
HF subjects managed with standard clinical assessment
干预措施: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) (Device)
结局指标
主要结局
Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
时间窗: 14.9 ± 5.4 months
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization
次要结局
未报告次要终点