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A Prospective Pilot Study (BIO|SELECT Pilot)

2021年1月26日更新者：Biotronik SE & Co. KG

A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response

Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.

研究概览

地位

完全的

条件

心脏衰竭

详细说明

Enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-Lead ECG) prior to the implantation of Biotronik CRT-D and QP lead featured with MultiPole Pacing parameter. At implantation, LV-LV conduction delays are measured in predefined LV pacing and sensing configurations. One month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming MultiPole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. Patients are subsequently followed up at four and seven month post implantation to acquire the LV-LV conduction delays and echo readings, etc. at the time.

研究类型

观察性的

注册 (实际的)

201

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

日本
- Tokyo
  - Mitaka、Tokyo、日本、181-8611
    - Kyorin University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The patient collective consists of heart failure patients with CRT-D indication according to clinical routine. Two hundred patients with successful device implantation will be enrolled in the clinical investigation.

描述

Inclusion Criteria:

To be eligible for the study enrollment, candidate patients must meet all of the following criteria

Indicated for a CRT-D implantation
Has never received CRT
Planned to be implanted with a quadripolar LV Lead, and CRT-D with MultiPole pacing feature, both manufactured by BIOTRONIK
Geographically stable and willing to comply with the required follow-up schedule
With written informed consent

Exclusion Criteria:

Candidate patients will not be eligible if either of the following criteria is applicable

Underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than CRT implantation
Life expectancy is less than a year
Can not be programmed to MultiPole pacing "ON"
Does not agree to the concept of HomeMonitoring System
With known pregnancy
At age below 20 years
Participated in another interventional clinical study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters 大体时间：through study completion, an average of 7 months	LV-LV/RV-LV intra-cardiac conduction time will be obtained at each time frame, and correlation will be investigated with variation of multiple hemodynamic parameters from baseline up to seven month follow up.	through study completion, an average of 7 months

次要结果测量

结果测量	措施说明	大体时间
Rate of arrhythmia episodes 大体时间：through study completion, an average of 7 months	Comparison between patient groups in terms of rate of arrhythmia	through study completion, an average of 7 months
Influence by baseline characteristics 大体时间：through study completion, an average of 7 months	An alanysis of the impact of the baseline characteristics on other outcomes	through study completion, an average of 7 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biotronik SE & Co. KG

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年11月7日

初级完成 (实际的)

2019年10月7日

研究完成 (实际的)

2019年10月7日

研究注册日期

首次提交

2017年10月24日

首先提交符合 QC 标准的

2017年11月8日

首次发布 (实际的)

2017年11月9日

研究记录更新

最后更新发布 (实际的)

2021年1月27日

上次提交的符合 QC 标准的更新

2021年1月26日

最后验证

2021年1月1日