Transaxillary TAVR guided only by echocardiography

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol performs transaxillary transcatheter aortic valve replacement using only echocardiographic imaging for intraprocedural guidance without routine fluoroscopy or contrast angiography. Eligible patients have symptomatic severe aortic stenosis by Doppler criteria and are anatomically suitable for axillary access. The team will record procedural success, intraprocedural and perioperative complications, valve function on follow-up echocardiography, and short-term clinical outcomes. The approach aims to define the feasibility and safety profile of sole echocardiography guidance in selected patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiangbin Pan, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Xiangbin Pan, MD
• Email: panxiangbin@fuwaihospital.org
• Phone: +8688396666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.