跳至主要内容
临床试验/NCT07453849
NCT07453849尚未招募不适用

Radiation- and Contrast-Free TAVR for Aortic Regurgitation Under Transesophageal Echocardiography Guidance

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
30-day Safety

研究概览

简要总结

Under contemporary practice, transcatheter aortic valve replacement (TAVR) is typically performed with fluoroscopic visualization and repeated injections of iodinated contrast. While effective, this paradigm introduces cumulative radiation exposure to both patients and staff and can be problematic in individuals with renal dysfunction, prior contrast reactions, or other situations where contrast use is undesirable. Treating native aortic regurgitation (AR) adds another layer of complexity: limited valvular/annular calcification, enlarged annular dimensions, and dynamic root motion may reduce frictional "purchase" and make prosthesis stabilization more demanding, thereby heightening the need for continuous, high-fidelity intraprocedural imaging. Transesophageal echocardiography (TEE), with its close acoustic window to the aortic root, provides detailed real-time information on annular geometry, cusp coaptation, LVOT-aortic root alignment, guidewire trajectory, and implant depth, and it allows immediate confirmation of valve function and rapid recognition of adverse events (e.g., significant paravalvular regurgitation, maldeployment, pericardial effusion, or coronary compromise). Leveraging TEE as the dominant imaging modality therefore represents a pragmatic pathway toward a low-radiation and potentially contrast-sparing-or in selected cases, contrast-free-TAVR workflow. Nevertheless, evidence supporting an "echo-only" TEE-guided approach remains sparse, especially for native AR. In this study, we present a standardized TEE-guided procedural protocol and report feasibility and early clinical outcomes of TEE-only TAVR in patients with aortic regurgitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Age ≥18 years.
  • Severe native aortic regurgitation (AR) confirmed by echocardiography (per guideline-recommended multiparametric assessment).
  • Indication for intervention, defined as symptomatic severe AR (e.g., NYHA class II-IV) or asymptomatic severe AR with evidence of LV decompensation (e.g., reduced LVEF and/or LV dilation per guideline thresholds).
  • Deemed appropriate for transfemoral TAVR by a multidisciplinary Heart Team (e.g., elevated/prohibitive surgical risk or other clinical/anatomic factors favoring transcatheter therapy).

排除标准

  • Active infective endocarditis or ongoing systemic infection/sepsis.
  • Aortic pathology requiring open surgery, such as significant ascending aortic aneurysm/root disease above surgical thresholds, acute aortic syndrome, or other conditions where surgery is mandated.
  • Annulus/landing-zone dimensions outside device range

研究组 & 干预措施

TEE Guided TAVR

Experimental

干预措施: TEE guided TAVR (Procedure)

结局指标

主要结局

30-day Safety

时间窗: 30-day follow-up post-procedure

30-day Early Safety (composite, VARC-3): occurrence of any of the following within 30 days: All-cause mortality Disabling stroke Life-threatening or major bleeding Major vascular complication Acute kidney injury stage 2-3 (or new dialysis) Coronary obstruction requiring intervention Valve-related dysfunction or malposition requiring repeat intervention (e.g., second valve, surgical conversion)

次要结局

未报告次要终点

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pan Xiangbin

Fuwai Hospital

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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