TAVR for Aortic Regurgitation Under TTE Guidance
Starting soon · Not applicable
Conditions studied: Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
In brief
Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or other contraindications. In patients with native aortic regurgitation, the absence of annular/leaflet calcification and frequent annular dilation can further complicate device positioning and anchoring, increasing the procedural dependence on precise imaging guidance. Transthoracic echocardiography (TTE) provides real-time assessment of valve anatomy, coaxial alignment, depth control, and immediate hemodynamic results, and-when used as the primary imaging modality-offers a potential "radiation- and contrast-free" alternative for selected patients. However, clinical evidence for fully TTE-guided (echo-only) TAVR remains limited. Here, the investigators describe our procedural workflow and evaluate the feasibility and early outcomes of total TTE-guided TAVR for treating aortic regurgitation.
Key facts
- Study ID
- NCT07458672
- Run by
- Chinese Academy of Medical Sciences, Fuwai Hospital
- People needed
- 30
- Starts
- 2026-03-10
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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