Medtronic CareLink® Network Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 10
- 主要终点
- Comparison of Remote Device Check and In-clinic Device Assessment
研究概览
简要总结
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
详细描述
Evaluation's objectives:
Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have an implanted Medtronic ICD, CRT-D device that is supported by the Medtronic CareLink® Network
- •Patients have to sign the Medtronic CareLink® "Statement of Privacy Principles" and the "Evaluation Data Protection Statement" documents
排除标准
- •Patients with exclusion criteria required by local law
- •Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)
结局指标
主要结局
Comparison of Remote Device Check and In-clinic Device Assessment
时间窗: Baseline to max. 12 months
"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"
次要结局
- Efficiency Through Increased Flexibility and Per Procedure Time(Baseline to max. 12 months)
- Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)(Baseline to max. 12 months)
- Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)(Baseline to max. 12 months)
- Time and Cost Savings for Patients(Baseline to max. 12 months)
- Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)(Baseline to max. 12 months)
- Time and Costs Savings for Physicians(Baseline to max. 12 months)
- Handling of Unscheduled Activities (for Example, Symptoms and Events)(Baseline to max. 12 months)