Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Lead failure after HV shock
研究概览
简要总结
Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values. The real prevalence of unrecognized "silent" lead failure in ICD patients remains unknown.
As a consequence, patients may be equipped with an ICD which is unable to provide life-saving shocks. The proposed registry aims to include patients presenting for ICD generator replacement or electrical cardioversion of atrial arrhythmia. The protocol mandates either a commanded synchronized high energy shock prior to generator replacement or internal cardioversion of atrial arrhythmia to provoke the unmasking of silent lead failure.
详细描述
Testing the ICD system during initial implantation was the standard of care for a long time. Since the publication of the SIMPLE trial, most centers have abandoned this practice for all uncomplicated, left-sided implantations of ICD. Remarkably, a high percentage of arrhythmia centers, including academic hospitals and high volume centers, routinely omit ICD testing at the time of ICD generator replacement. There is no data available to support the safety of this practice, and findings from the SIMPLE trial may not be extrapolated to the ICD generator replacement (ICD-GR) setting.
Data from case reports and own data from an ongoing multicenter randomized trial on internal vs. external cardioversion of ICD patients suggest that a relevant number of ICD patients carry a defective defibrillation lead with normal electrical parameters. Such "silent" lead failure may only be uncovered through a high voltage (HV) ICD shock during ICD testing or internal cardioversion. An in vitro trial suggests the common low-voltage measurement of shock impedance is not able to detect smaller insulation breaches leading to short circuits. Identification of these leads and patients is crucial to ensure the continuous adequate function of ICD therapy throughout the patients' lifespan. Omitting ICD testing during all subsequent generator exchanges many years after initial implantation, may thus put patients' safety at risk.
Investigators aim to assess the magnitude of silent ICD lead failure prevalence and to identify associated risk factors.
The objectives of this study are:
- Main objective: To determine the prevalence of silent lead failure in contemporary ICD patients with chronically implanted ICD leads, presenting for elective ICD generator replacement (ICD-GR) or electrical cardioversion of atrial arrhythmia in Germany.
- To identify risk factors predisposing to silent lead failure.
- To identify possible differences in the prevalence of silent lead failure between ICD lead models and manufacturers.
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
- •Age ≥ 18 years
- •Informed, written consent
- •Status post ICD implantation, including CRT-D
- •Battery in EOL, ERM or ERI, ERT with indication for elective ICD generator replacement or patients presenting for electrical cardioversion for atrial arrhythmia.
排除标准
- •Age < 18 years
- •Pregnancy
- •Patients under guardianship or with mental disorders/disabilities
- •Recent adequate and successful ICD shock therapy (within the past 12 months)
- •Patients in the cardioversion arm with low battery (<1 year to ERI/RRT)
- •Patients with intracardiac thrombus
- •Participation in any other investigational study that may interfere with interpretation of the study and registry results
- •Indications of an already compromised RV lead (Pacing impedance <200 or >2000 Ohm, Pacing threshold >5V/0.4ms, RV Sensing <4mV, HV impedance >80, presence of lead noise)
- •Systems with recalled leads or leads known to have an elevated failure risk: Riata™ and Riata ST™ (St. Jude Medical, St. Paul, Minnesota, USA), Sprint Fidelis™ (Medtronic, Minneapolis, Minnesota, USA)
结局指标
主要结局
Lead failure after HV shock
时间窗: 3 hours within testing
Any single or combination of the following observations: * HV impedance \>20 Ohm * Pacing impedance \>2000 Ohm * Pacing threshold \>5V/0,4ms * Pacing threshold increase by factor 2 or more * Pacing exit block * Sensing \< 4mV * Relative decrease in sensing by 50% or more * Detection of lead noise or artifacts on the RV pace-sense or shock channel * Any lead associated error reports by the ICD preventing delivery of the ICD shock
次要结局
- Changes in Device Function not leading to primary outcome(3 hours within testing)
- Adverse events within shock testing(3 hours within testing)
- Rhythm after synchronized shock(3 hours within testing)