Transaxillary TAVR With Solely Echocardiography Guidance
Recruiting now · Not applicable
Conditions studied: Aortic Stenosis
In brief
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).
Key facts
- Study ID
- NCT07035847
- Run by
- Chinese Academy of Medical Sciences, Fuwai Hospital
- People needed
- 20
- Starts
- 2024-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Fuwai Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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