Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23,472
- 试验地点
- 1
- 主要终点
- Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure.
研究概览
简要总结
The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.
详细描述
Background:
Over the last several decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, a bridge to recovery, and as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years.
Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including infection, thrombosis, and device failure. The development of new procedures and devices to reduce these complications will be expedited by the work of the registry involving the systematic, independent analysis of MCSD implantation procedures and outcomes. The National Heart, Lung, and Blood Institute (NHLBI) will collaborate with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures, and adverse events.
Intermacs Design Narrative:
The goals of the registry include the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
- •Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
排除标准
- •Currently incarcerated
结局指标
主要结局
Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure.
时间窗: Collected as part of the registry
次要结局
未报告次要终点