Aortic Regurgitation
Conditions
Keywords
Aortic Regurgitation, transcatheter aortic valve replacement, 3D simulation technology, DIGITAL
Brief summary
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.
Interventions
DEVICE3D simulation technique
using 3D simulation technique
Sponsors
Xijing Hospital
Fu Wai Hospital, Beijing, China
West China Hospital
Beijing Anzhen Hospital
General Hospital of Ningxia Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Henan Provincial Chest Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Fujian Medical University Union Hospital
Guangdong Provincial People's Hospital
Xinqiao Hospital of Chongqing
The Affiliated Hospital of Qingdao University
First Affiliated Hospital Xi'an Jiaotong University
Yan'an Hospital of Kunming City
Dong'e People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All of the following conditions must be met for inclusion: 1. Age ≥ 65 years; 2. Symptomatic severe native aortic regurgitation; 3. Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ; 4. Subjects signed a written informed consent and agreed to cooperate with all follow-up examinations.
Exclusion criteria
* Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coaxial ratio of prosthetic aortic valve | 12 months | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death, Disabling stroke, Myocardial infarction, and Heart failure | 30 days | Number of patients that had any of these events |
| Technical success | immediate postoperative | 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 |
| All-cause mortality | 30 days,12 months | Rate of all-cause mortality |
| Device success | 30 days | 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) |
| Myocardial infarction | before discharge, 30 days, 12 months | Number of patients that had event |
| Incidence of coronary obstruction | before discharge | Number of patients that had event |
| CT imaging changes | 12 months | 1\) New aortic sinus volume formed after prosthetic valve implantation2) Low density leaflet thickening/leaflet thrombosis on prosthetic valve |
| New York Heart Association Functional Classification | before discharge, 30 days , 12 months | — |
| Evaluation cardiac function by electrocardiography | 30 days,12 months | Left ventricular ejection fraction (%) |
| Evaluation of bioprosthesis performance by echocardiography | 30 days,12 months | Using the following measures:Aortic Valve Mean Gradient (cm2) |
| Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment | immediate postoperative | 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 |
| Major Cardiac Structural Complications | before discharge, 30 days | Number of patients that had these events |
Countries
China
Outcome results
None listed