ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy (NCT07453407) | Clinical Trial Compass
RecruitingNot Applicable
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
China1,250 participantsStarted 2026-03-05
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. LVEF ≤55%
. LVESD \>50 mm
. LVESDi \>22 mm/m2
. LVESVi \>45 mL/m2
. 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),
Exclusion criteria
. Aortic Annulus Perimeter \<53 mm or \>94 mm measured by CT
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All-cause mortality
Timeframe: 12 months
2
All stroke
Timeframe: 12 months
3
Unplanned cardiac rehospitalization
Timeframe: 12 months
Trial details
NCT IDNCT07453407
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy
. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).
. Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.
. Unprotected left main coronary artery disease ≥50%
. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is \>2.5 mm