Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
研究概览
简要总结
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
详细描述
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR).
Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University.
Planned Study Period: 2017-2023.
Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.
Design: Prospective, randomized, open-label, multi-centre trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1)
- •Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope
- •Patient is evaluated for TAVR
排除标准
- •Contraindications to perform CMR
- •Contraindications to perform CT
- •Contraindications for TAVR or reduced life expectancy < 1 year.
- •Known hypersensitivity to CMR or CT contrast agents
- •Childbearing potential or inability to exclude pregnancy
- •Inability to understand and follow study-related instructions
- •Severe renal insufficiency requiring renal replacement therapy
- •Severe hepatic insufficiency (Child-Pugh class B or C)
- •Post organ transplantation
- •Participation in another clinical study
结局指标
主要结局
The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
时间窗: 6 months
The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient \< 20mmHg and no valve regurgitation \> mild)
次要结局
未报告次要终点