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Transaxillary TAVR With Solely Echocardiography Guidance

RECRUITINGN/ASponsored by Chinese Academy of Medical Sciences, Fuwai Hospital
Actively Recruiting
PhaseN/A
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
Started2024-10-01
Est. completion2026-12-31
Eligibility
Healthy vol.Accepted

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).

Eligibility

Healthy volunteers accepted
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.

Conditions2

Aortic StenosisHeart Disease

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