ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator Patients: A Prospective, Single-arm Safety Monitoring Study (ENHANCED-ICD Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of intervention-related safety events
研究概览
简要总结
The purpose of this study is to determine whether Enhanced device programming to reduce therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.
详细描述
ICD therapy has become the first-line treatment for the prevention of sudden cardiac death both as primary and secondary prevention due to its proven survival benefits as compared to anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and shocks that may impair patient quality of life and well being but also influence mortality. Hence, reduction of ICD shocks by means of alternative programming of the device is paramount for improving patient-centered outcomes and mortality.
The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All patients will receive Enhanced programming. Furthermore, patients will be asked to complete a set of standardized and validated self-report questionnaires prior to ICD implantation, at 3-, 6-, and 12 months post implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a primary or secondary prophylactic indication for ICD therapy according to the current European guidelines
- •implanted with a Medtronic ProtectaTM ICD/CRT-D device or any future CE-approved and market-released Medtronic ICD/CRT-D devices with SmartShock technology
- •between 18-80 years of age
- •speaking and understanding Dutch
- •providing written informed consent
排除标准
- •a life expectancy less than 1 year
- •a history of psychiatric illness other than affective/anxiety disorders
- •on the waiting list for heart transplantation
- •insufficient knowledge of the Dutch language
结局指标
主要结局
Number of intervention-related safety events
时间窗: up to 12 months
Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.
次要结局
- Quality of life(12 months post implantation)
- Distress(12 months post implantation)
- Number of ATPs/shocks(12 months post implantation)
研究者
M. Meine
Mathias Meine, MD, PhD
UMC Utrecht