TAVR for Aortic Regurgitation Under TTE Guidance

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.

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Key information

Conditions

Aortic Regurgitation Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Transcatheter Aortic Valve Replacement (TAVR)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTE guided TAVR

Procedure

Intraprocedural TTE 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. Peri-procedural anticoagulation, anesthesia strategy, and post-procedure medical therapy will follow institutional standards.

Primary outcomes

30-day Early Safety

Time frame: 30-day follow-up

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangbin Pan, MD

CONTACT

[email protected]

+86 88396655

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 9, 2026
Registry last updated: Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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