Transaxillary TAVR With Solely Echocardiography Guidance

Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07035847

Enrollment

Registered

2025-06-25

Start date

2024-10-01

Completion date

2026-12-31

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Brief summary

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

PROCEDUREEchocardiography guided TAVR

Echocardiography guided TAVR

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. 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) 2. suitable for Transaxillary TAVR

Exclusion criteria

1. required hybrid procedures or concomitant interventions on other cardiac malformations 2. inoperable due to extremely high surgical risk or severe comorbidities 3. untreated clinically significant (\>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization 4. previously undergone aortic valve replacement.

Design outcomes

Primary

Measure	Time frame	Description
Valve Academic Research Consortium-3	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.

Countries

China

Contacts

CONTACTXiangbin Pan, MD

panxiangbin@fuwaihospital.org+8688396666

CONTACTXu Wang, MD

+86 88396655

PRINCIPAL_INVESTIGATORXiangbin Pan, MD

Chinese Academy of Medical Sciences, Fuwai Hospital

STUDY_DIRECTORXu Wang, MD