TAVR for Aortic Regurgitation Under TEE Guidance

NCT07453849 | Not Yet Recruiting

• 1 other identifier: 20260303
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Regurgitation; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TEE Guided TAVR

EXPERIMENTAL

Procedure: TEE guided TAVR

Interventions

TEE guided TAVR PROCEDURE

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.

TEE Guided TAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiangbin Pan

CONTACT

+8688396666; panxiangbin@fuwaihospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fuwai Hospital

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)