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临床试验/NCT01999140
NCT01999140招募中不适用

Implantable Cardioverter Defibrillator (ICD Registry)

American College of Cardiology1 个研究点 分布在 1 个国家目标入组 1,750 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,750
试验地点
1
主要终点
Risk Adjusted Complications and Death Composite Measure

研究概览

简要总结

The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry captures the characteristics, treatments, and outcomes of patients receiving (ICDs). Patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both a volume peer group (number of ICD patients submitted annually) and the entire ICD registry data set.

详细描述

In January 2005 the Centers for Medicare and Medicaid Services (CMS) expanded the covered indications for primary prevention implantable cardioverter defibrillators (ICDs) to incorporate the findings from the Sudden Cardiac Death Heart Failure Trial (SCDHeFT) and the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). As part of this expansion, CMS mandated that a national registry be formed to compile data on Medicare patients implanted with primary prevention ICDs to confirm the appropriateness of ICD utilization in this patient population.

Responding to this mandate, a collaborative effort of the Heart Rhythm Society (HRS)and the American College of Cardiology Foundation (ACCF), utilizing the expertise of the National Cardiovascular Data Registry (NCDR®), developed the ICD Registry™. Enrollment opened on June 1, 2005. CMS selected the NCDR ICD Registry as the mandated national registry in October 2005.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients who receive an ICD/CRT-D (initial or generator change) for primary or secondary prevention purposes.
  • All patients with an ICD/CRT-D undergoing a Lead Only procedure.
  • U.S. populations must submit all patients who receive an ICD/CRT-D (initial or generator change) for primary prevention purposes who are insured by Medicare.

排除标准

  • 未提供

结局指标

主要结局

Risk Adjusted Complications and Death Composite Measure

时间窗: Post-procedure until discharge occurences. Reported quarterly based on a rolling 1 year of data.

Reported as one value for a composite measure looking at the following complications and death: Cardiac arrest, cardiac perforation, coronary venous dissection, hemothorax, device-related infection, lead dislodgement, mortality, myocardial infarction, pericardial tamponade, pneumothorax, stroke/transischemic attack (TIA), urgent cardiac surgery, hematoma, set screw problem

次要结局

未报告次要终点

研究者

发起方
American College of Cardiology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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