跳至主要内容
临床试验/NCT04167579
NCT04167579招募中不适用

The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) Registry

Hoag Memorial Hospital Presbyterian1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
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 was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

详细描述

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 forpost market studies.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

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 days from procedure

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

次要结局

  • Mortality(1 year)
  • Major adverse cardiac and cerebrovascular events(1 year from procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colleen Balius

CLINICAL DATA COORDINATOR (RN)

Hoag Memorial Hospital Presbyterian

研究点 (1)

Loading locations...

相似试验