Monitoring in Dialysis Clinical Study India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- The primary objective of this study is to estimate the proportion of hemodialysis subjects
研究概览
简要总结
The purpose of this study is to characterize and estimate the occurrence of arrhythmic events in
hemodialysis patients through ext
ended continuous cardiac monitoring using Medtronic’s Reveal® XTInsertable Cardiac Monitor (ICM) system. Additionally, the study will explore the correlation of
arrhythmias recorded by the Reveal® XT with specific ESRD treatment characteristics, including preand
post-dialysis serum electrolyte changes, variations in dialysis session parameters, and changes in
background medications. Finally, this study will explore patterns of arrhythmic events detected by
the Reveal® XT which may be predictive of hospitalizations or severe cardiovascular events (e.g.,
sudden cardiac death, stroke, acute myocardial infarction, onset or worsening of congestive heart
failure, etc.).
The proposed study is an interventional post-market release study.
Subjects selected to participate in the study include those who are diagnosed with ESRD and are
currently on hemodialysis at least thrice-weekly or those subjects with an estimated glomerular
filtration rate (eGFR) <15 mL/min/1.73m
2 who will begin hemodialysis within two months of theReveal® XT implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Subject is 21 years of age or older • Subject is willing to be implanted with the Reveal® ICM • Subject has been diagnosed with ESRD and on hemodialysis at least three times per week OR has an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73m2 and is expected to begin hemodialysis within 2 months of the Reveal® ICM implant, in the opinion of the investigator • Subject is willing and able to comply with the protocol, including sending data to the Medtronic CareLink® Network using a CareLink® Monitor as requested.
排除标准
- •â€¢ Subject is currently enrolled in an interventional study that may interfere with the Monitoring in Dialysis protocol.
- •Enrollment into another observational study is permitted • Subject not suitable for Reveal® ICM implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to 6 months), in the opinion of the investigator • Subject with an existing hemodialysis catheter that exits the left chest wall below the clavicle and may interfere with the Reveal® ICM implantation site, in the opinion of the investigator • Subject with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic) infection within 14 days • Subject has end-stage liver failure, as determined by the investigator • Subject has had thoracic surgery within the past 6 months • Subject has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization devices • Subject who is scheduled for renal transplantation or will likely be transplanted within 6 months, in the opinion of the investigator • Subject that is currently on home hemodialysis, is scheduled to transition to home hemodialysis or to peritoneal dialysis within 6 months, in the opinion of the investigator.
结局指标
主要结局
The primary objective of this study is to estimate the proportion of hemodialysis subjects
时间窗: within 6 months after first dialysis session post device- implant
cardiac monitoring with an implanted Medtronic Reveal® ICM device.
时间窗: within 6 months after first dialysis session post device- implant
experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous
时间窗: within 6 months after first dialysis session post device- implant
次要结局
- To characterize the rate of device and procedure related adverse events (AEs) associated(with the use of the Reveal® XT in ESRD patients.)