SAFEty of Two Strategies of ICD Management at Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,120
- 试验地点
- 1
- 主要终点
- Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
研究概览
简要总结
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator
详细描述
The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD
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
- •first implantation of ICD or CRT-D
- •Patients undergoing upgrade to ICD or CRT-D from pacemaker
- •Patients undergoing upgrade to CRT-D from CRT
- •Age 18 or above, or legal age to give written informed consent
排除标准
- •Patients who do not give consent to treat their data.
结局指标
主要结局
Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
时间窗: 2 years
* Severe implant-related\* complications at ICD implants among the following: * Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation. * Transient ischemic attack or stroke, * Cardiogenic shock, * Pulmonary edema, * Embolic events, * Anoxic coma * Pericardial tamponade * Death. * Events at follow up: * Sudden cardiac death (defined as witnessed unexpected death occurring \<1 hour from symptoms onset or unwitnessed during sleep) * Resuscitation after ineffective documented appropriate ICD shocks * Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure.
次要结局
- Severe Intra-operative Complications(Acute (ICD implant))
- Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up(2 years)