Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Insufficiency
Conditions
Keywords
Aortic Regurgitation, TAVR, SAVR, RCT
Brief summary
The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.
Interventions
DEVICEJ-VALVE Transfemoral Aortic Valve system
Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system
DEVICECommercially available surgical biological aortic valve replacement device
Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
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
* 1\) Age ≥65 years； * 2\) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters 1. LVEF ≤55% 2. LVESD \>50 mm 3. LVESDi \>22 mm/m2 4. LVESVi \>45 mL/m2 5. normal LV systolic function at rest (LVEF \>55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension \[LVEDD\] \>65 mm), * 3\) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement * 4\) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits
Exclusion criteria
* 1\. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation * 2\. Moderate or severe aortic valve stenosis * 3\. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention * 4\. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion) * 5\. Subject is high-risk for SAVR as determined by the local heart team * 6\. Subject refuses SAVR as a treatment option * 7\. Subject is selected for aortic valve repair or aortic surgery * 8\. Need for emergency surgery or TAVR for any reason * 9\. Anatomical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 12 months | All-cause mortality at 12 months |
| All stroke | 12 months | Number of patients with stroke |
| Unplanned cardiac rehospitalization | 12 months | Number of patients who had unplanned cardiac rehospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New-onset atrial fibrillation | 30 days | Comparing the onset of atrial fibrillation in TAVR with SAVR |
| Echocardiographic effective orifice area | 30 days | Comparing echocardiographic effective orifice area in TAVR with SAVR |
| Moderate or greater patient prosthesis mismatch as measured by echocardiography | 30 days | Comparing moderate or greater patient prosthesis mismatched in TAVR with SAVR |
| Cardiovascular rehospitalization | 30 days | Comparing the number of cardiovascular rehospitalizations in TAVR with SAVR |
| Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23) | 30 days | Comparing change in KCCQ-23 in TAVR with SAVR. The KCCQ score ranges from 0 to 100, with higher scores indicating better quality of life. |
| Length of index hospitalization | Pre-intervention/procedure surgery | Comparing TAVR length of index hospitalization with SAVR |
| Composite primary endpoints | 30 days | Comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR |
Countries
China
Contacts
CONTACTJian'an Wang, MD
PRINCIPAL_INVESTIGATORJian'an Wang, MD
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed