TAVR for Aortic Regurgitation Under TTE Guidance

NCT07458672 | Not Yet Recruiting

• 1 other identifier: 20260302
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aortic Regurgitation; Transcatheter Aortic Valve Replacement (TAVR)

Outcome Measures

Primary Outcomes (1)

• 30-day Early 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

Study Arms (1)

TTE Guided TAVR

EXPERIMENTAL

Participants assigned to this arm will undergo total transthoracic echocardiography (TTE)-guided transcatheter aortic valve replacement (TAVR) for treatment of significant native aortic regurgitation. The procedure will be performed using a commercially available transcatheter heart valve and standard delivery system, with procedural planning and all key steps and immediate post-deployment evaluation-guided primarily by real-time TTE without routine fluoroscopy or iodinated contrast.

Procedure: TTE guided TAVR

Interventions

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.

TTE 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

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiangbin Pan, MD

CONTACT

+86 88396655; 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: Principle Investigator

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 9, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share