Fuwai Hospital
Beijing, Beijing Municipality, China
Location status: Recruiting
NCT Number: NCT06517537
This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.
Interested in participating?
Request Info50 year–70 year
All sexes
Observational
Beijing, Beijing Municipality, China
Location status: Recruiting
Small aortic annulus (SAA), which is prevalently observed in patients with severe aortic stenosis (AS), constitutes a significant challenge in treatment and may give rise to post-operative prosthetic valve mismatch (PPM) and an elevated late mortality rate. The optimal approach for treating SAA remains controversial. Transcatheter aortic valve replacement (TAVR) has yielded superior valvular hemodynamic outcomes in patients with SAA; however, the incidence of PPM subsequent to surgery remains considerable. Aortic root enlargement (ARE) represents an effective solution for SAA, but the conventional method of aortic ring enlargement for ARE has restricted efficacy. In 2021, Yang Bo proposed an enhanced ARE approach, where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction, enabling the enlargement of the number 3-5 of the aortic ring
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Before discharge, 3 months after surgery, and 1 year after surgery
Prospective collection of all echocardiographic data before surgery and upon discharge, measuring mean aortic valve area (EOA), mean transvalvular pressure gradient, and the degree and type of aortic regurgitation (AR). According to the patient's BSA calculation of iEOA, 0.65-0.85cm2/m2 is diagnosed as moderate PPM, and<0.65cm2/m2 is diagnosed as severe PPM.
Contact information is provided by the study sponsor or research team.
jianing cui, bachelor
CONTACT
xiao peng hu, doctor
CONTACT
China National Center for Cardiovascular Diseases
Other Gov
The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
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