Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Successful"In-Clinic LVAT" Test
研究概览
简要总结
The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.
详细描述
"In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups:
- first visit: planned to be conducted 15 days maximum after inclusion
- second visit: planned to be conducted between 1 and 3 months after the first visit The evaluation consists in the comparison between the threshold value provided by the algorithm and the threshold value obtained manually by the physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]:
- •With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or;
- •With IS4 Platinium SonR CRT-D (model 1844, CE-marked).
- •Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
- •Reviewed, signed and dated informed consent.
排除标准
- •Subject included in another clinical study that could confound the results of this study;
- •Malfunction or dislodgment of right atrial, right and left ventricular implanted leads;
- •Subject diagnosed with permanent atrial fibrillation;
- •Known pregnancy;
- •Minor age;
- •Under protection or guardianship;
- •Unavailability for scheduled follow-up or refusal to cooperate
研究组 & 干预措施
"In-Clinic LVAT"
All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up.
干预措施: "In-Clinic LVAT" (Device)
结局指标
主要结局
Percentage of Successful"In-Clinic LVAT" Test
时间窗: 0-3 months post inclusion
The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.
次要结局
- Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer(0-15 days post inclusion)
- Percentage of Successful "In-Clinic LVAT" Test at M1 Visit(1-3 months after first visit)
- Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit(0-15 days post inclusion)
- Percentage of Eligible Subjects to LVAT Feature(0-3 months post inclusion)
- Safety of the LVAT Algorithm(0-3 months post inclusion)