Menu
Recruiting NCT07035847

Transaxillary TAVR With Solely Echocardiography Guidance

No phase Interventional Aortic Stenosis

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: Echocardiography guided TAVR.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: No limits · 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
China
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

Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance

Overview

This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).

Interventions

  • Procedure Echocardiography guided TAVR
    Echocardiography guided TAVR

Primary outcome measures

  • Valve Academic Research Consortium-3 [Time frame: 30 days after intervention]

Eligibility criteria

Inclusion criteria

  • symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2)
  • suitable for Transaxillary TAVR

Exclusion criteria

  • required hybrid procedures or concomitant interventions on other cardiac malformations
  • inoperable due to extremely high surgical risk or severe comorbidities
  • untreated clinically significant (>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
  • previously undergone aortic valve replacement.

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

China · 1 center
  • Fuwai Hospital — Beijing

Identifiers

NCT: NCT07035847 · 2025-0501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗