Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes
研究概览
简要总结
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.
Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
详细描述
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.
Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
Primary Endpoint:
- First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Indication for implanting of a single chamber ICD (primary or secondary prevention) according to current guidelines;
- •Sustained sinus rhythm as the current prevalent atrial rhythm;
- •Planned de novo implantation with a BIOTRONIK single chamber DX ICD system;
- •Patient is able to understand the nature of study and to provide written informed consent;
- •Patient is willing and able to perform all follow up visits at the study site;
- •Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
排除标准
- •Age < 18 years
- •Any limitation to contractual capability;
- •Female patients who are pregnant or breast feeding or planning pregnancy during the course of the study;
- •Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment;
- •Life expectancy < 2 years;
- •Patient is participating in any other interventional clinical investigation.
结局指标
主要结局
New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes
时间窗: 12 months
All patients enrolled presented with sinus rhythm, confirmed also during the implant. Outcome was considered positive with the occurence of first confirmed episode of Atrial Fibrillation (AF) or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to BIOTRONIK's Home Monitoring Service Center (HMSC), lasting at least 30 seconds to be considered relevant. The adjudication was carried out by the independent investigator in charge of the remote monitoring.
次要结局
- Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform(12 months)
- Cardiologic Hospitalization(12 months)
- Device Related Complication(60 days)