Actively Recruiting
Transcatheter Aortic Valve Replacement With Echocardiography Guidance
Led by Pan Xiangbin · Updated on 2025-06-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with symptomatic severe aortic stenosis (AS) who require aortic valve replacement. It explores a method called echocardiography-guided transcatheter aortic valve replacement (Echo TAVR) as a safer alternative to the conventional TAVR, which usually uses fluoroscopy and contrast agents. This approach is particularly important for high-risk patients who should avoid radiation and contrast exposure. The procedure uses echocardiography instead of traditional imaging methods to guide the valve replacement. This method aims to reduce risks associated with radiation and contrast agents, making it a potentially safer option for certain patients. The study observes patients undergoing this echocardiography-guided procedure without comparing to other treatments. Participants in the study will be monitored for outcomes related to the safety and effectiveness of the Echo TAVR procedure. The main measure will be the Valve Academic Research Consortium-3 (VARC-3) criteria assessed 30 days after surgery. The study will collect data on clinical results following the procedure to evaluate this newer guidance method. Participation involves follow-up evaluations around one month after treatment.
CONDITIONS
Brief Title
Echocardiography Guided TAVR (Echo TAVR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic severe aortic stenosis confirmed by echocardiography requiring valve replacement with mean gradient 640 mmHg, peak velocity 64 m/s, and valve area 61 cm2 (or indexed valve area 60.6 cm2/m2)
- History of malignancy or high family risk of cancer with refusal of contrast or radiation procedures
- Chronic kidney disease with refusal to receive contrast agents or radiation exposure
You will not qualify if you...
- Need for hybrid or additional heart procedures on other malformations
- Considered inoperable due to very high surgical risk or severe other illnesses
- Untreated significant coronary vascular disease suitable for revascularization
- Previous aortic valve replacement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days after surgery
Participants who undergo routine care for valve replacement are observed using echocardiography guidance without additional interventions.
1 to 2 visits depending on clinical follow-up
Trial Site Locations
Total: 1 location
1
Fuwai Hospital
Beijing, China, 100037
Actively Recruiting
Research Team
X
Xiangbin Pan, MD
F
Fengwen Zhang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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