BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 21
- 主要终点
- Number of implantation of a right atrial lead after conclusion of the initial study device implantation
研究概览
简要总结
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
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
- •Patient is able to understand the nature of study and has provided 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.
- •CRT-D is indicated according to the current ESC guidelines.
- •De novo implantation with no pre-existing defibrillator or pacemaker system
- •Patient is in sinus rhythm without history of persistent or permanent atrial fibrillation.
- •Patient has no atrioventricular (AV) block II or III.
- •Patient has no evidence of impaired sinus node function.
- •Patient has no need for atrial stimulation, has a resting heart rate (HR) > 40 b.p.m and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment
- •NYHA class II or III
- •Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment
排除标准
- •Patient is pregnant or breast feeding.
- •Patient is less than 18 years old.
- •Patient is participating in an interventional clinical investigation.
- •Life-expectancy is less than 1 year.
- •Patient has tachycardia-bradycardia syndrome
- •Any standard contraindication for CRT-D
- •Frequent premature ventricular contractions (PVC rate > 5 %/h) examined within 3 months prior to enrollment by appropriate routine method (e.g. 24 h holter electrocardiogram)
结局指标
主要结局
Number of implantation of a right atrial lead after conclusion of the initial study device implantation
时间窗: through study completion, on average 12 months
次要结局
- Number of lead complications requiring an invasive re-intervention(through study completion, on average 12 months)
- Number of post-operative system revisions requiring an invasive re-intervention(through study completion, on average 12 months)
- Number of device or pocket infections requiring an invasive re-intervention(through study completion, on average 12 months)