Left Ventricular Capture Management (LEARN) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
研究概览
简要总结
Primary Objective:
To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.
Study Design:
This is a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design, based on the primary objective, is an observational examination of LV thresholds over time. Daily left ventricular threshold measurements will be collected using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary objective at up to 15 study centers.
Data will be collected at Baseline, Implant, 12 months post-implant and all regularly scheduled follow-up visits up to 12 months post-implant.
Devices:
The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM feature will be used in this study.
详细描述
I. Study Purpose:
The purpose of the LEARN Study is to provide information that will assist clinicians in managing LV thresholds.
II. Device Description:
The CRT-ICD devices to be used in this study are all Therapeutic Products Directorate licensed, market released Medtronic CRT-ICD devices equipped with the LVCM feature. Currently this includes only the ConcertoTM CRT Defibrillator. Future Medtronic models equipped with the LVCM feature that become Therapeutic Products Directorate licensed and market released in the future are also included.
The study will allow all commercially available leads from all manufacturers that are compatible with Medtronic CRT-ICD devices. Devices will be programmed and interrogated with a Medtronic 9790 or 2090 programmer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be implanted with their first CRT defibrillator system.
- •Patients who will be implanted with a Medtronic CRT defibrillator containing the LVCM feature.
- •Patients who are willing and able to sign an IRB/MEC approved patient informed consent.
- •Patients who are geographically stable and available for follow-up at the study center for the required follow-up duration of the study
排除标准
- •Patients who have a pre-existing LV lead prior to enrollment
- •Patients who have a life expectancy of less than 1 year
- •Patients included in another clinical trial that will affect the objectives of this study