Feature Assessment Study for Indications Based Programming
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 28
- 主要终点
- Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
研究概览
简要总结
The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.
详细描述
"This study will focus on documenting the final parameter changes that are made in comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history. It will therefore compare the device settings that were finally programmed during the last available follow up procedure to the last available parameter recommendations of IBP. IBP was designed to facilitate programming by providing customized parameter settings based on a patient's clinical needs and primary indication.
In order to further enhance the IBP feature for future device generations, additional data may be collected and evaluated on:
- Physician perception and satisfaction with the New User Interface (NUI) of the programming application;
- Motivation for adapting IBP recommendations for the final programming of the device;
- Device data that can be retrieved from patient data disks that may include but is not limited to, arrhythmia episode detail, pacing counter data; total and individual therapy data"
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
- •indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines
- •Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
- •Geographically stable patients who are available for follow-up at a study centre
- •Age 18 or above, or of legal age to give informed consent specific to national law
排除标准
- •Inability or refusal to sign the Patient Informed Consent
- •Pregnant or planning to become pregnant
- •Replacement device
- •Enrolment in another clinical trial, study or evaluation
- •Estimated life expectancy of less than six months per discretion of physician
结局指标
主要结局
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
时间窗: 6 Months
次要结局
- - Degree of acceptance of IBP - Proportion parameters changed per patient - Differences between recommended and final programmed parameters - Total number of parameter changes from IBP recommendations - Frequency of changes made to a single parameter(6 Months)