NCT00500838已完成不适用
CRT-D Based Impedance Monitoring Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
研究概览
简要总结
The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.
详细描述
This is a multi-center feasibility study intended to collect information on changes in intra-thoracic impedance measurements from CRT-D devices. In order to obtain an intra-thoracic impedance measurement, the device delivers a subthreshold impulse that measures the resistance between two electrodes.
At the programmed interval, measurements will be obtained between six different lead configurations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Eligible patients will meet all of the following:
- •Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) or have a previously implanted St. Jude Medical (SJM) CRT-D system capable of enabling the diagnostic impedance monitoring feature with implant occurring within the last 14 days
- •Have had at least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of ≥100% over a 24 hour period
- •Have the ability to maintain a patient diary for recording daily weights, symptoms related to heart failure, changes in diuretic therapy, and any unscheduled clinic or hospital visits
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation
排除标准
- •Patients will be excluded if they meet any of the following:
- •Be less than 18 years of age
- •Have had a recent myocardial infarction, unstable angina or cardiac revascularization within 40 days of enrollment
- •Have had a recent Cerebrovascular Accident or Transient Ischemic Attack within three months of enrollment
- •Have a contraindication for an emergency thoracotomy
- •Have an indication that requires programming device in atrial pacing mode
- •Have permanent (chronic) atrial fibrillation
- •Have a capped or inactive right atrial or right ventricular pacing/defibrillator lead
- •Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
- •Be pregnant or planning a pregnancy in the next 6-months
- •Be currently participating in a clinical investigation that includes an active treatment arm
- •Have a life expectancy of less than six months due to any condition
研究组 & 干预措施
1
Experimental
Transthoracic impedance device implanted.
干预措施: Transthoracic Impedance (Device)
结局指标
主要结局
To assess the use of the impedance feature in conjunction with other functions of the CRT-D device
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Dynamic Thoracic Impedance as a Marker for Heart Failure DecompensationHeart Failure With DecompensationNCT02134379Charles Porter, MD11
招募中
不适用
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure PatientsHeart FailureNCT06604468Centre hospitalier de l'Université de Montréal (CHUM)30
已完成
不适用
Detect Fluid Early From Intra-thoracic Impedance MonitoringHeart FailureNCT00916929Abbott Medical Devices162
已完成
不适用
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear ImplantHearing LossNCT06173687Cochlear51
已完成
不适用
Electrical Impedance Imaging of Patients With Cystic FibrosisCystic FibrosisNCT02524704Colorado State University44