RECRUITINGINTERVENTIONAL

Transaxillary TAVR With Solely Echocardiography Guidance

Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

Echocardiography guided TAVR

Locations (1)

Fuwai Hospital

Beijing, Beijing Municipality, China