Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- CRT-responder rate based on improvement in Clinical Composite Score developed by Packer at 12 month follow up.
研究概览
简要总结
BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality. However, additional clinical data on the short and mid-term improvement of CRT-D patients by the CRT AutoAdapt feature are needed.
详细描述
The magnitude of clinical and hemodynamic benefit of CRT varies significantly among its recipients. Many studies report that approximately one-third of the implanted population show no clinical improvement at follow-ups. There are many clinical factors that are associated with the CRT response and the grade of benefit, such as type of cardiomyopathy, severity of electrical conduction abnormalities, dyssynchrony, and scar burden. In addition, there are device-related factors such as lead location, insufficient ventricular pacing percentage (%V), and suboptimal atrial-ventricular (AV) and ventricle- ventricle (VV) timing.
The main finding in such CRT non-responders is a suboptimal AV-timing (47%). The optimization of AV and VV intervals during biventricular (BiV) pacing is an option to maximize the positive effects of CRT, by taking advantage of the full atrial contraction for optimal filling of the ventricles. Optimization is usually accomplished by using echocardiography or other methods. However, such methods are time consuming for the hospitals and may not provide a benefit for every patient.
The most common pacing mode for CRT therapy is BiV pacing, but many acute and chronic randomized clinical studies have demonstrated that left-ventricular (LV) pacing can be at least as effective as BiV pacing. In patients with sinus rhythm and normal atrioventricular (AV) conduction, pacing the left ventricle only with an appropriate AV interval can result in an even superior LV and right ventricular (RV) function compared with standard BiV pacing. LV pacing has been proposed as an alternative approach to apply cardiac resynchronization as it has been shown that LV pacing induces short-term hemodynamic benefits compared to BiV pacing.
Different algorithms have been developed by different manufactures to provide continuous automatic CRT optimization, allowing a more physiologic ventricular activation and greater device longevity in patients with normal AV conduction due to the reduction of unnecessary RV pacing. Studies with the Medtronic Adaptive cardiac resynchronization therapy (aCRT) algorithm, that provides automatic ambulatory selection between synchronized LV or BiV pacing with dynamic optimization of atrioventricular and interventricular delays, have shown that the algorithm is safe and as effective as BiV pacing with comprehensive echocardiographic optimization.
The CRT AutoAdapt feature by BIOTRONIK optimizes the CRT therapy settings of the device automatically and continuously. This algorithm adjusts the AV delay and sets the ventricular pacing configuration to BiV or LV. The settings are based on intracardiac conduction times, which are measured every 60 seconds to select the optimal configuration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 de novo implantation or upgrade to a CRT-D device
- •Enrolled in BIO|STREAM.HF but not yet implanted with or upgraded to CRT-D
- •LVEF < 35%
- •QRS > 120 ms
- •NYHA II-IV
- •Atrial heart rate during sinus rhythm at rest below 100 bpm
- •Patient is able to understand the nature of the study and willing to provide written informed consent to this submodule
排除标准
- •Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- •History of persistent/permanent AF
- •History of complete AV-block
研究组 & 干预措施
Control group
This group will be made up of patients implanted with CRT-D devices without the CRT AutoAdapt feature, or with the CRT AutoAdapt feature deactivated.
干预措施: Echocardiography AV optimization (Procedure)
Control group
This group will be made up of patients implanted with CRT-D devices without the CRT AutoAdapt feature, or with the CRT AutoAdapt feature deactivated.
干预措施: Echocardiography (Procedure)
Control group
This group will be made up of patients implanted with CRT-D devices without the CRT AutoAdapt feature, or with the CRT AutoAdapt feature deactivated.
干预措施: Self Assessment Score (Other)
AutoAdapt group
This group will be made up of patients implanted with CRT-D devices that have the CRT AutoAdapt feature available. It is mandatory that all patients within this group have the feature activated, independently of other characteristics.
干预措施: Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature. (Procedure)
AutoAdapt group
This group will be made up of patients implanted with CRT-D devices that have the CRT AutoAdapt feature available. It is mandatory that all patients within this group have the feature activated, independently of other characteristics.
干预措施: Echocardiography (Procedure)
AutoAdapt group
This group will be made up of patients implanted with CRT-D devices that have the CRT AutoAdapt feature available. It is mandatory that all patients within this group have the feature activated, independently of other characteristics.
干预措施: Self Assessment Score (Other)
结局指标
主要结局
CRT-responder rate based on improvement in Clinical Composite Score developed by Packer at 12 month follow up.
时间窗: 12 month Follow Up
It will be use Packer Score to assess the clinical outcome in heart failure patients. It takes into account all possible dimensions of outcome, i.e. mortality, morbidity and quality of life and is based on the following data points: * Death (yes/no) * Any unplanned hospitalization for worsening heart failure (yes/no) * Change in NYHA class compared to baseline (improved/unchanged/worsened) * Patient's global assessment (PGA) compared to baseline (improved - three stages / unchanged / worsened - three stages) * Discontinuation of study protocol due to worsening heart failure, treatment failure or lacking therapeutic response (yes/no) At the end of the study, the outcome of each patient is classified as: * Worsened * Unchanged * Improved
次要结局
- Acute hemodynamic effect of AutoAdapt feature(At pre-hospital discharge assessed up to 30 days since the implantation)
- Change in Left Ventricular End Diastolic and Systolic Diameter (LVED(S)D)(12 month Follow Up)
- Change in LVEF(12 month Follow Up)
- Change in NYHA class(12 month Follow Up)
- Percentage of LV only pacing(12 month Follow Up)
- Change in Left Ventricular End Diastolic and Systolic Volumes (LVED(S)V)(12 month Follow Up)
- Adverse device effects related to the CRT AutoAdapt feature(12 month Follow Up)
