Transaxillary TAVR guided only by echocardiography
Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance
This tests whether doing transaxillary TAVR using only echocardiography is safe and practical for people with severe aortic stenosis who are suitable for axillary access.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07035847 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with symptomatic severe aortic stenosis who meet the echocardiographic severity criteria and are anatomically suitable for transaxillary access without need for other concomitant cardiac interventions.
Not a fit: Patients who have had prior aortic valve replacement, require concomitant cardiac procedures, have untreated significant proximal coronary disease amenable to revascularization, or are inoperable due to extremely high surgical risk are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable TAVR without radiation or iodinated contrast, which may reduce kidney injury risk and simplify imaging needs in selected patients.
How similar studies have performed: Transaxillary access for TAVR is an established route, but performing the entire procedure guided solely by echocardiography is relatively novel with only limited case series and no large-scale evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.