NCT03402126已完成不适用
Tachy Prediction Download Study
Medtronic Cardiac Rhythm and Heart Failure16 个研究点 分布在 2 个国家目标入组 138 人开始时间: 2018年1月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 16
- 主要终点
- Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
研究概览
简要总结
The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.
详细描述
The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:
- •Secondary Prevention or,
- •Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF
- •Subject is ≥ 18 years old
- •Subject has previously documented history of VT/VF
- •Subject must be willing and able to use Medtronic CareLink network monitoring system
- •Subject provides signed and dated authorization and/or consent per institution and local requirements
- •Subject is willing and able to comply with the protocol
排除标准
- •Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF
- •Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- •Subject has chronic AF
- •Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
- •Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
- •Subject has active electronic medical device other than an ICD
- •Subject requires more than 25% atrial or ventricular pacing
- •Subject has medical conditions that would limit study participation (per investigator judgment)
- •Subject has projected life expectancy of less than 1 year
- •Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study)
- •Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
结局指标
主要结局
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
时间窗: 1 year
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
次要结局
未报告次要终点
研究者
研究点 (16)
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