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临床试验/NCT05344456
NCT05344456已完成不适用

Switching PVC Response ''Atrial Pace'' in ST JUDE Medical or Abbott ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) Devices to Off Mode Decreases the Burden of Atrial Tachycardia

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay.

研究概览

简要总结

Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response algorithm ''Atrial Pace''. In this algorithm the PVARP (Post Ventricular Atrial Refractory Period) is extended to 480ms but the initial 150ms of the PVARP is deemed absolute. If atrial sensed event occurs after absolute PVARP the PVARP terminates and atrial pace follows after 330ms alert period. Two case reports exists where patients atrial tachycardia were suspected to be induced by this algorithm. In Helsinki University Hospital an index patient with multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the tachycardias was suspected to be the PVC response algorithm ''Atrial Pace''. After programming the algorithm from Atrial Pace to off mode the patient had none atrial tachycardias during 2021. After investigating all the patients with physiological ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) device and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with similar atrial tachycardia episodes possibly induced by the PVC response ''Atrial Pace''.

详细描述

The device of the subjects participating to the study is interrogated and the PVC response algorithm is switched from ''Atrial Pace'' to ''Off'' mode.

Subjects are also requested to fulfill the EQ-5D-3L and ICD8 questionaries before the change in the device programming and after the 12 months surveillance.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ST Jude Medical or Abbott physiological ICD or CRT-D device
  • PVC response setting ''Atrial Pace''
  • Atrial tachycardia episode duration > 30s preceded by ventricular extrasystole and atrial pace in year 2020 or 2021

排除标准

  • Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
  • PVC response has been switched off before enrollment

结局指标

主要结局

Number of atrial tachycardia episodes per participant which is initiated after PVC followed by atrial sensed event and atrial pace after 330ms delay.

时间窗: The number of these episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.

Atrial tachycardia episode is considered as an episode which duration is \>30s and atrial rate \> 180 beats per minute.

Number of any atrial tachycardia episodes and overall duration of atrial tachycardia episodes per participant.

时间窗: The number of these episodes and overall duration of all atrial tachycardia episodes is compared between year 2020 and 12 months preceding the change in the programming setting and 12 months afterwards.

Atrial tachycardia episode is considered as an episode which duration is \>30s and atrial rate \> 180 beats per minute.

次要结局

  • Composite Change in the quality of life analyzed with EQ-5D-3L and ICD8 questionaries'.(baseline and after 12 months surveillance)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Sane

M.D, PhD, Cardiologist

Helsinki University Central Hospital

研究点 (1)

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