Micra Atrial Tracking Using a Ventricular Accelerometer Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 25
- 主要终点
- MARVEL Evolve Substudy
研究概览
简要总结
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.
A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 has been implanted with, or is expected to be implanted with a MicraTM TPS (Model MC1VR01), with remaining device longevity of 6 years or more.
- •Subject is ≥ 18 years old and as per required local law.
- •Subject has atrioventricular (AV) block.
- •Subject (and/or witness, as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
- •Subject is willing and able to comply with the protocol.
排除标准
- •Subject is in atrial arrhythmia at the time of enrollment.
- •Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- •Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL study procedures).
- •Subject meets any exclusion criteria required by local law (age or other).
- •Additional criteria for the MARVEL Evolve Sub-study:
- •Inclusion criteria:
- •Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study
研究组 & 干预措施
Enrolled
Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device.
干预措施: MARVEL algorithm (Device)
结局指标
主要结局
MARVEL Evolve Substudy
时间窗: Initial 24 hour period after patient enrollment
Characterize the rate of atrioventricular synchrony provided by the MARVEL algorithm and compare the accelerometer signal amplitudes and the AV synchrony provided by the MARVEL algorithm with the data collected during the initial MARVEL procedure.
Atrioventricular synchrony
时间窗: Initial 24 hour period after patient enrollment
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
次要结局
未报告次要终点