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NOT YET RECRUITING
NCT07453849
NA

TAVR for Aortic Regurgitation Under TEE Guidance

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-01

Completion Date

2026-12-31

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

PROCEDURE

TEE guided TAVR

TEE will be used to assess valve position and function, transvalvular gradients, paravalvular leak, and pericardial effusion, and to direct any adjunctive maneuvers (e.g., repositioning, post-dilation, or second-valve implantation) as clinically indicated.

Locations (1)

Fuwai Hospital

Beijing, Beijing Municipality, China