跳至主要内容
临床试验/NCT01737528
NCT01737528招募中不适用

Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).

The Society of Thoracic Surgeons1 个研究点 分布在 1 个国家目标入组 16,000 人开始时间: 2012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
16,000
试验地点
1
主要终点
Major adverse cardiac and cerebrovascular events

研究概览

简要总结

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis.

详细描述

Purpose of the Registry

The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post market studies.

Background and Significance

Transcatheter valve therapies are now emerging into clinical practice from the research phase in the United States. The first of several approaches to replacing the aortic valve without open-chest surgery has now become a reality. Other valve and delivery systems are expected to be approved in the upcoming years. An Expert Consensus Document on Transcatheter Valve Therapy has outlined the initial technology, targeted patient population, and the multidisciplinary heart team and specialized facilities needed. The document also proposes the establishment of a national registry of patients with valvular heart disease that can collect and analyze data as these new valve treatment options become available. Surveillance of device performance, monitoring of long-term outcomes, and performance of comparative effectiveness research are some of the proposed uses of the registry.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Major adverse cardiac and cerebrovascular events

时间窗: 30 day

increase in the 30-day risk of adverse events among patients receiving TAVR

次要结局

  • Mortality(1 year)

研究者

发起方
The Society of Thoracic Surgeons
申办方类型
Other
责任方
Sponsor

研究点 (1)

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