This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR. The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure. Secondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria
The purpose of this study is to evaluate the safety and efficacy of TF-TAVR for the treatment of isolated aortic regurgitation. The study will compare all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after TAVR. Additionally, the study will assess the incidence of hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) via CTA, as well as the aortic valve root-prosthesis coaxiality. Changes and differences between groups in the following parameters will be evaluated using transthoracic echocardiography at 6 and 12 months after enrollment: left ventricular ejection fraction (Simpson method), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic diameter (LVESd), estimated aortic valve orifice area, valvular regurgitation, and transvalvular pressure gradient compared with baseline. The study will also compare changes and differences between groups in the Minnesota Living with Heart Failure Questionnaire, Social Support Rating Scale (SSRS), International Physical Activity Questionnaire (IPAQ), and 6-minute walk test (6MWT) at 6 and 12 months after enrollment compared with baseline. Furthermore, the study will compare surgical costs, potential complication costs, and disease-related costs between the two groups.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system. The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
The patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve.
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGClinical worsening
The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.
Time frame: 12 months
Rate of procedural complications
The rate of any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation, reoperation of heart valve.
Time frame: 12 months
6-minute walk distance
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time frame: 12 months
New York Heart Association (NYHA) functional class
Classification of function capacity of the NYHA.
Time frame: 12 months
Rate of hypoattenuated leaflet thickening
The rate of hypoattenuated leaflet thickening. Hypoattenuated leaflet thickening（HALT）defined by VARC-3
Time frame: 12 months
Rate of reduced leaflet motion
Rate of reduced leaflet motion. Reduced leaflet motion（RLM）defined by VARC-3.
Time frame: 12 months
Rate of Stroke
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Time frame: 12 months
Mortality
All-cause, cardiovascular, and non-cardiovascular mortality
Time frame: 12 months
Rate of bleeding complications
Rate of bleeding complications. The original VARC definitions with BARC classifications
Time frame: 12 months
Rate of prothetic valve dysfunction
The rate of any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Time frame: 12 months
Rate of rehospitalization
The rate of rehospitalization due to valve-related symptoms or worsening congestive heart failure.
Time frame: 12 months
Quality of life assessment (Minnesota Living with Heart Failure Questionnaire, MLHFQ)
Total score of Minnesota Living with Heart Failure Questionnaire (MLHFQ). The total score ranges from 0 to 105, with higher scores indicating a greater impact of heart failure on quality of life and worse outcome..
Time frame: 12 months
Quality of life assessment (social supporting raing scal, SSRS)
Total score of social supporting raing scal (SSRS). The total score ranges from 0 to 40, with higher scores indicating a higher level of social support.
Time frame: 12 months
Quality of life assessment (International Physical Activity Questionnaire, IPAQ)
Total score of International Physical Activity Questionnaire (IPAQ). The total score is calculated by multiplying the frequency and duration of each activity by its respective MET value, and then summing these products. The result is a measure of the total energy expenditure from physical activity in MET-minutes per week.The total score can be used to classify individuals into different physical activity levels, such as low, moderate, or high.
Time frame: 12 months
Treatment costs
Including surgical costs, potential complications costs, and disease-related costs
Time frame: 12 months
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