TAVR for Aortic Regurgitation Under TEE Guidance

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Regurgitation; Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Procedure: TEE guided TAVR

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangbin Pan; Phone Number: +8688396666; Email: panxiangbin@fuwaihospital.org

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Fuwai Hospital
      • Contact: Jie Dong; Phone Number: 18311384217; Email: jennidong97@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEE Guided TAVR	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day Safety	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)	30-day follow-up post-procedure

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: 20260303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No