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临床试验/NCT01805739
NCT01805739招募中不适用

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)

Klinik für Kardiologie, Pneumologie und Angiologie1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2013年1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
5,000
试验地点
1
主要终点
Implantation depth (ID) measured from NCC in fluoroscopic view

研究概览

简要总结

Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.

The aim of the study is to compare the different imaging modalities for aortic root measurements.

Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.

The study will be performed retrospectively (2009-2012) and prospectively starting 2013.

详细描述

Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.

The aim of the study is to compare the different imaging modalities for aortic root measurements.

Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.

The study will be performed retrospectively (2009-2012) and prospectively starting 2013.

Substudy: "Real-World Experience with Implantation Depth Optimization according to 2020 Recommendations for Evolut R Self-Expanding Transcatheter Aortic Valve: the Düsseldorf Best Practice Trial." Aortic valve stenosis treated by transcatheter aortic valve replacement (TAVR) is one of the most fast-growing sections in interventional cardiology. The Heart Center Düsseldorf is a high-volume center for treatment of patients suffering of aortic stenosis treated by TAVR, so we have a great interest in further investigation of process optimizing and improvement. Therefore, we will focus on optimization of implantation depth (ID) according to Medtronic®'s best practice recommendations for TAVR deployment in July 2020 regarding new-generation devices Medtronic® CoreValve Evolut. Optimal ID is an important condition for hemodynamic and clinical outcome due to increased risk of paravalvular leakage or even valve embolization in implantation that is located too high, whereas deep implantation is associated with more aortic regurgitation an increased risk of conduction disturbances associated with higher rates of permanent pacemaker implantation. The aim of this single-center observational study is to investigate short-term clinical performance, safety and efficiency outcomes in patients undergoing transfemoral TAVR regarding Medtronic®'s best practice advices of July 2020 for TAVR deployment with CoreValve Evolut.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • aortic valve stenosis
  • screened for TAVI
  • written informed consent

排除标准

  • unconsciousness, not able to consent

结局指标

主要结局

Implantation depth (ID) measured from NCC in fluoroscopic view

时间窗: baseline

Assessment of diameters of the aortic annulus using the different imaging modalities

时间窗: baseline

次要结局

  • mean pressure gradient(baseline)
  • left ventricular contrast injection(baseline)
  • Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).(baseline)
  • bleeding and vascular access site complications(baseline)
  • paravalvular aortic regurgitation(baseline)

研究者

发起方
Klinik für Kardiologie, Pneumologie und Angiologie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

研究点 (1)

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