NCT05754138招募中不适用
Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator
Eli Sprecher, MD1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Tachyarrhythmia-related death or externally resuscitated cardiac arrest due to S-ICD
研究概览
简要总结
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
详细描述
Observational multicenter study with prospective follow-up but accepting also retrospectively collected data. Data will be collected and entered in a secure dedicated web-based database.
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
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (male or female) is <60 years of age.
- •Patient has an implanted with a new-generation S-ICD [Boston Scientific EMBLEM, Generations 2 (model A209), 3 (A219) or newer].
- •Present device is the first defibrillator implanted.
- •Patient has a functioning LATITUDE™ Home-Monitoring-System at home, knows how to use it and sends weekly reports via the home-monitoring system.
- •Patient actively participates in sport activities above a predefined level of exercise (see below).
- •Patient understands that, at present, there is virtually no data on the safety of sport participation for patients with implanted S-ICD system, particularly regarding potential damage caused by sport activities to the S-ICD system, including the subcutaneous electrode.
- •Patient understands that the level of sport activity, type of sport and frequency of exercise activities are entirely at his/her own discretion and responsibility.
- •Patient understands that The Sport S-ICD Study investigator neither encourage nor discourage performance of any given sport.
- •Patient understands that The Sport S-ICD Study is not liable for- and does assume any responsibility for any damages caused by sport participation to the implanted system or the health of patients participating in the study.
- •Patient is willing to provide informed consent to participate in the SPORT S-ICD Study. Informed consent includes agreement to provide all the following information:
- •Clinical data (age, gender, clinical diagnosis, indication for S-ICD implantation, arrhythmic events since S-ICD implantation, adverse events since S-ICD implantation)
- •Type and level of exercise and sport participation at the time of inclusion and during follow-up.
- •Information concerning endpoint events during follow-up.
- •Direct access to the patients' LATITUDE™ Home-Monitoring-System data, both at the time of inclusion and all weekly reports during the follow-up period, until the study ends or the informed consent is revoked. Access to the personal LATITUDE™ Home-Monitoring-System data is in addition to the access by the primary treating physician and only for purpose of data collection for the study. Consent from the patient AND for the primary treating physician (monitoring the patient's LATITUDE data) are required. Once the study ends, participating patients will be notified that the Study Investigators are no longer monitoring his/her LATITUDE Home-Monitoring-System.
排除标准
- •Subjects with an inability to communicate well with the investigators.
- •Subjects who are non-cooperative or unwilling to sign consent form.
- •Evidence suggestive of malfunction of the implanted S-ICD system (like abnormal impedance or detected noise) at the time of screening
结局指标
主要结局
Tachyarrhythmia-related death or externally resuscitated cardiac arrest due to S-ICD
时间窗: 5 years
Quantitative data will be reported by S-ICD interrogation including shock failure, incessant ventricular arrhythmia, or post-shock pulseless electrical activity.
次要结局
- S-ICD Lead fracture/malfunction(5 years)
研究者
Eli Sprecher, MD
Deputy director general for R&D
Tel-Aviv Sourasky Medical Center
研究点 (1)
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