BIO|MASTER.Edora Family Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- (S)ADEs and calculation of the SADE free rate
研究概览
简要总结
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.
详细描述
Study Design
- Open-label, prospective, non-randomized, multicenter, international
- about 13 study sites
Study Endpoints
The following endpoints are defined and will be assessed with descriptive analysis:
- AV Opt feature:
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
- •Standard indication for pacemaker therapy or cardiac resynchronization therapy
- •Patient is able to understand the nature of the study;
- •Patient provides written informed consent;
- •Patient is able and willing to complete the planned follow-up visits at the investigational site;
- •Patient accepts Home Monitoring® concept;
- •Age ≥ 18 years.
排除标准
- •Any contraindication for pacemaker or cardiac resynchronization therapy (whichever applies);
- •Patient has received or is planned to receive an epicardial LV lead implant;
- •Pregnant or breast-feeding;
- •Life expectancy of less than 6 months;
- •Participation in an interventional clinical investigation
结局指标
主要结局
(S)ADEs and calculation of the SADE free rate
时间窗: until the 6-month follow-up
Descriptive analysis of all (S)ADEs and calculation of the SADE free rate
Overall score for the usability of the LV VectorOpt feature
时间窗: until the 1-month follow-up
The LV VectorOpt feature has to be assessed for patients with an HF-T device (triple-chamber) and a QP lead (quadripolar, HF-T QP group) only. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.
时间窗: until the 1-month follow-up
The AV Opt Feature will be assessed only for patients with triple-chamber devices and patients with dual-chamber devices (if clinically indicated) with sinus rhythm of sufficient intrinsic rate. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.
次要结局
未报告次要终点