TAVR for Aortic Regurgitation Under TTE Guidance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TTE guided TAVR.
- Who it may be relevant to
- Registry conditions: Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance
Overview
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.
Interventions
- Procedure TTE guided TAVR
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 outcome measures
- 30-day Early Safety [Time frame: 30-day follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07458672 · 20260302