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NCT Number: NCT07035847

Transaxillary TAVR With Solely Echocardiography Guidance

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).

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Xiangbin Pan

CONTACT

[email protected]

088396666

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Echocardiography guided TAVR

Procedure

Echocardiography guided TAVR

Primary outcomes

  1. Valve Academic Research Consortium-3

    Time frame: 30 days after intervention

    Outcomes were reported according to the VARC-3 criteria.Which include: Technical success: Evaluated immediately post-procedure (e.g., successful vascular access, device delivery, deployment, no immediate complications).

    Device success: Includes successful valve function with acceptable hemodynamics and positioning.

    Procedural success: Includes 30-day outcomes, combining technical/device success and absence of major complications.

Study contacts

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

Xiangbin Pan, MD

CONTACT

[email protected]

+8688396666

Xu Wang, MD

CONTACT

+86 88396655

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Feb 27, 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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