An interventional study of 3D simulation technique in Aortic Regurgitation, sponsored by Xijing Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation technology using a prospective, randomized controlled study.
162 studies on the registry are indexed under Aortic Valve Insufficiency; 52 are open to participants now.
This study's planned enrollment of 354 is above the median of 112 across 88 interventional studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All of the following conditions must be met for inclusion:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria were not included:
Using 3D simulation technique
Device: 3D simulation technique
Not using 3D simulation technique
using 3D simulation technique
Coaxial ratio of prosthetic aortic valve
Definition: A coaxial index of less than 4 degrees or a coaxial angle of less than 10 degrees is considered coaxial if one of them is met, and the ratio of coaxial prosthetic aortic valves in the two groups test group (with 3D simulation technique) or control group (without 3D simulation technique) is calculated, respectively Coaxial rate per group = number of coaxial aortic valve prostheses per group/total number of cases per group 100%
Time frame: 12 months
All-cause death, Disabling stroke, Myocardial infarction, and Heart failure
Number of patients that had any of these events
Time frame: 30 days
Technical success
No operative mortality;Successful puncture, device delivery and delivery system retrieval;Correct positioning and release of a single bioprosthetic aortic valve to the appropriate anatomical location;No device-related procedures or interventions, no major vascular or access-related complications, and no structural cardiac complications
Time frame: immediate postoperative
All-cause mortality
Rate of all-cause mortality
Time frame: 30 days,12 months
Device success
Technical success • Freedom from death • No device-related procedures or interventions, no major vascular or access-related complications, and no structural cardiac complications • The performance of the bioprosthetic aortic valve meets clinical requirements (mean aortic valve gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥0.25 and \< moderate aortic regurgitation)
Time frame: 30 days
Myocardial infarction
Number of patients that had event
Time frame: before discharge, 30 days, 12 months
Incidence of coronary obstruction
Number of patients that had event
Time frame: before discharge
CT imaging changes
1\) New aortic sinus volume formed after prosthetic valve implantation2) Low density leaflet thickening/leaflet thrombosis on prosthetic valve
Time frame: 12 months
New York Heart Association Functional Classification
Time frame: before discharge, 30 days , 12 months
Evaluation cardiac function by electrocardiography
Left ventricular ejection fraction (%)
Time frame: 30 days,12 months
Evaluation cardiac function by electrocardiography
Left ventricular end diastolic diameter (mm)
Time frame: 30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Using the following measures:Aortic Valve Mean Gradient (cm2)
Time frame: 30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Using the following measures:Transaortic peak velocity
Time frame: 30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Using the following measures:Transaortic Central Regurgitation Severity
Time frame: 30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Using the following measures:Perivalvular Leak Severity
Time frame: 30 days,12 months
Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment
Valve Dislodgement: Following initial correct positioning, the prosthesis moved upward or downward within the aortic annulus from its initial position without valve embolization Valve embolization: Prosthesis moves upward or downward after final deployment, thereby losing contact with the aortic annulus Ectopic Valve Deployment: Prosthesis deployed in unintended location and unable to be explanted due to valve embolization or inability to deliver valve to intended location
Time frame: immediate postoperative
Major Cardiac Structural Complications
Number of patients that had these events
Time frame: before discharge, 30 days
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Xijing Hospital