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临床试验/NCT05603026
NCT05603026招募中不适用

Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Peak gradient

研究概览

简要总结

The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

详细描述

Project Overview/Summary Transcatheter aortic valve replacement (TAVR) is an alternative to open heart surgery for the treatment of severe aortic stenosis, and has recently been approved for low surgical risk patients. This has resulted in a shifting of TAVR patient demographics to younger and more active individuals. It is, therefore, imperative to deliver excellent hemodynamics after valve replacement to enable patients to recover an active lifestyle with enhanced exercise capacity. Several studies, mostly conducted with resting echocardiogram have suggested self-expanding valves (SEV) Evolut R, Evolut PRO, Evolut PRO+ (Medtronic , Minneapolis, MN) are associated with favorable hemodynamics, which may allow for improved exercise capacity in active patients.

Currently, there are different TAVR valves are commercially available in the United States. The Sapien 3 valve (Edwards Lifesciences, Irvine, CA) is an annular, balloon expandable valve (BEV) and the Evolut PRO+ valve features a supra-annular design and is a SEV. A recent study utilizing resting echocardiogram demonstrated better hemodynamics of supra-annular SEV compared with BEV, mostly in patients with smaller annuli.

Cardiac magnetic resonance (CMR) has emerged as an important tool in the non-invasive assessment of patients with valvular heart disease. While CMR has been used for the diagnosis and quantification of valvular heart disease, there is a paucity of data on its use for the assessment of valvular hemodynamics in the post TAVR setting. Furthermore, it would be of utmost importance to understand how these devices perform during exertion. Of note, cardiac magnetic resonance techniques permit quantification of the myocardial extracellular volume fraction (ECV), representing a surrogate marker of reactive interstitial fibrosis, and late gadolinium enhancement (LGE), representing replacement fibrosis or scar. ECV and LGE have been independently linked with heart failure (HF) events.

Several studies have demonstrated that non-invasive CMR can be used to calculate non-invasive pressure-volume loops using cine imaging and non-invasive brachial blood pressure. This enables assessment of myocardial performance beyond LVEF. CMR-derived myocardial stroke work is a novel method allowing non-invasive assessment of total active myocardial performance, including both constructive and wasted myocardial work. Specifically, changes in LV stroke work have been shown to carry important prognostic information following TAVR.

Hypothesis The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
  • •Planned transfemoral TAVR; 18 years of age or older;
  • •Able to give informed consent.

排除标准

  • •Patients with permanent pacemakers or implantable defibrillators;
  • •Patients with non-MRI safe implants;
  • •Severe claustrophobia;
  • •Inability or contraindication to perform exercise bike stress test;
  • •Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
  • •Reduced left ventricular systolic function (<40%);
  • •History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
  • •Significant non-treated coronary artery disease.

研究组 & 干预措施

TAVR using the self-expanding valve Evolut FX

Active Comparator

Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Medtronic Evolut FX supra-annular self-expanding valve

干预措施: Self-expanding valve (Medtronic Evolut FX) (Device)

TAVR using the balloon-expandable valve Sapien 3 Ultra RESILIA

Active Comparator

Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Edwards Sapien 3 Ultra valve

干预措施: Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA) (Device)

结局指标

主要结局

Peak gradient

时间窗: 1-year

Mean AV gradient assessed by CMR (mmHg)

Mean gradient

时间窗: 1-year

Mean AV gradient assessed by CMR (mmHg)

Effective orifice area (EOA)

时间窗: Baseline, 30-days and 1-year

Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2)

次要结局

  • Exercise capacity post TAVR(30-days)
  • Myocardial fibrosis(1-year)
  • Composite of morbidity and mortality associated with TAVR(1-year)
  • Myocardial extra-cellular volume fraction(1-year)
  • Mean gradient by echo(1-year)
  • Stress CMR feasibility(30-days)
  • EOA by echo(1-year)
  • Ejection fraction by echo(1-year)

研究者

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

Guilherme Attizzani, MD

Physician

University Hospitals Cleveland Medical Center

研究点 (1)

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