ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy

Recruiting now · Not applicable

Conditions studied: Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency

In brief

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.

Key facts

Study ID

NCT07453407

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

1250

Starts

2026-03-05

Expected to finish

2038-03-01

Last updated by the study team

2026-03-10

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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),
• 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

You may not qualify if…

• 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 exclusion criteria (ANY of the following):
• Aortic Annulus Perimeter <53 mm or >94 mm measured by CT
• Maximal ascending aortic diameter ≥50 mm
• 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.
• 10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit
• 11. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit
• 12. Any condition considered a contraindication to mechanical circulatory support
• 13. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.)
• 14. Subject refuses blood transfusion
• 15. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
• 16. Evidence of acute myocardial infarction within 30 days of the screening visit
• 17. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)
• 18. Complex coronary artery disease (one of the following):
• 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

Where it is running

• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Prince of Wales Hospital — Hong Kong, Hong Kong, China
• Queen Mary Hospital — Hong Kong, Hong Kong, China
• Nanjing First Hospital — Nanjing, Jiangsu, China
• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• Cheng Hsin General Hospital — Taibei, Taiwan, China
• National Taiwan University Hospital — Taibei, Taiwan, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Xijing Hospital affiliated to Air Force Medical University — Xi'an, Shaanxi, China

Full record on ClinicalTrials.gov

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