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临床试验/NCT03865043
NCT03865043已完成不适用

Vascular Complications and Bleeding After Transfemoral TAVI: a Comparison Between Surgical and Percutaneous Approaches

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
vascular complications and bleeding

研究概览

简要总结

Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery.

However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results]. No data are available comparing both approaches performed by the same team during the same period.

The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.

详细描述

This prospective monocentric observational study aims to include all patients undergoing TAVI via transfemoral access from November 2017 at Montpellier University Hospital, France.

All procedures are performed in the same site by 7 medical teams including 4 different surgeons and 9 interventional cardiologists.

All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and are deemed for TAVI after heart team decision.

Before the procedure, a multislice computerized tomography (MSCT) is systematically performed to evaluate the aortic annulus, the aorta and to determine the access site.

The choice of percutaneous or surgical is at operators' discretion, according to predictable access site difficulties (calcifications, tortuosity femoral bifurcation height) and global considerations as obesity.

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

vascular complications and bleeding

时间窗: 1 day (at the end of hospitalization)

The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification

次要结局

  • amount of radiation(1 day (at the end of hospitalization))
  • Other complications after TAVI(1 day (at the end of hospitalization))
  • amount of contrast(1 day (at the end of hospitalization))
  • procedure duration(1 day (at the end of hospitalization))
  • hospitalization length(1 day (at the end of hospitalization))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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