Evaluation of Atrio-ventricular Synchronous Pacing Rate During Exercise Test in Patients With a VDD Leadless Pacing System (Micra AV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Characterize the AV synchrony percentage provided by the Micra AV during exercise.
研究概览
简要总结
The study is a non-randomized, active prospective observational study permitting to report the behavior of Micra AV pacemaker during an exercise.
Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. Exercise test is part of the standard clinical care practice for this patients population during the first year follow-up.
详细描述
The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise:
- Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
- Characterize the AV synchrony percentage provided by the Micra AV during exercise.
- Confirm the safety of the Micra AV during exercise
Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. All subjects provide signed and dated consent that he/she is willing and able to comply with the protocol.
Retrospective patients enrollment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.
Exercise test The Micra AV permits AV synchronous pacing mode up to a maximal sinus rate of 115/min. Exercise test will therefore be performed up to a maximal heart rate of 115/min. The test will be stopped by the patient (depending on his/her ability/symptoms such as: fatigue, dyspnea, leg pain,..) or by the cardiologist if a maximal heart rate of 115 beats per minute is reached.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients previously implanted with a Micra MC1AVR01
- •Signed and dated consent (patient confirms that he/she is willing and able to comply with the protocol)
- •Patient is physically able to perform an exercise test (cycle test).
- •Retrospective patients enrolment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.
- •Co-enrolment in the Micra AV post-approvals study is allowed.
排除标准
- •Frail patient unable to perform an exercise test (cycle test).
结局指标
主要结局
Characterize the AV synchrony percentage provided by the Micra AV during exercise.
时间窗: Exercise test is performed during the first year following the Micra implantation
Characterize the AV synchrony percentage provided by the Micra AV during exercise.
Confirm the safety of the Micra AV during exercise
时间窗: Exercise test is performed during the first year following the Micra implantation
Confirm the safety of the Micra AV during exercise confirmed by the absence of (1) pauses exceeding 2 paced cardiac cycles and (2) oversensing induced tachyarrhythmia exceeding 130 bpm.
Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
时间窗: Exercise test is performed during the first year following the Micra implantation
Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
次要结局
未报告次要终点