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

J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency
• Intervention / Treatment: Device: J-VALVE Transfemoral Aortic Valve system; Device: Commercially available surgical biological aortic valve replacement device

• Study Type: Interventional
• Enrollment (Estimated): 1250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian'an Wang, MD; Phone Number: +86-571-8778-4808; Email: wangjianan111@zju.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Not yet recruiting
      • Beijing Anzhen Hospital Affiliated to Capital Medical University
      • Contact: Guangyuan Song, MD; Phone Number: +86-106-441-2431; Email: songgy_anzhen@vip.163.com
      • Contact: Haibo Zhang, MD; Phone Number: +86-106-441-2431; Email: zhanghb2318@163.com
    • Beijing, Beijing Municipality, China, 100000
      • Not yet recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Xiangbin Pan, MD; Phone Number: +86-106-831-4466; Email: xiangbin428@hotmail.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Not yet recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Huiming Guo, MD; Phone Number: +86-208-382-7812; Email: guohuiming@gdph.org.cn
  • Hong Kong
    • Hong Kong, Hong Kong, China, 999077
      • Not yet recruiting
      • Queen Mary Hospital
      • Contact: Simon Lam, MD; Phone Number: 852-2255; Email: drsimonlam@gmail.com
    • Hong Kong, Hong Kong, China, 999077
      • Not yet recruiting
      • Prince of Wales Hospital
      • Contact: Kent So, MD; Phone Number: +85-235-052-211; Email: kentso987@gmail.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Not yet recruiting
      • Nanjing First Hospital
      • Contact: Junjie Zhang, MD; Phone Number: +86-255-227-1000; Email: jameszll@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Not yet recruiting
      • Xijing Hospital affiliated to Air Force Medical University
      • Contact: Jian Yang, MD; Phone Number: +86-298-477-4114; Email: yangjian1212@hotmail.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Not yet recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Lai Wei, MD; Phone Number: +86-216-404-1990; Email: Wei.lai@zs-hospital.sh.cn
  • Taiwan
    • Taibei, Taiwan, China, 100-116
      • Not yet recruiting
      • Cheng Hsin General Hospital
      • Contact: Jeng Wei, MD; Phone Number: +86-228-264-400; Email: jengwei@mac.com
    • Taibei, Taiwan, China, 100116
      • Not yet recruiting
      • National Taiwan University Hospital
      • Contact: Hsien-Li Kao, MD; Phone Number: 022-312-3456; Email: hsienli_kao@yahoo.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Jian'an Wang, MD; Phone Number: +86-571-8731-5001; Email: wangjianan111@zju.edu.cn
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Liang Ma, MD; Phone Number: +86-571-8723-6114; Email: 992960615@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria (ANY of the following):

  1. Aortic Annulus Perimeter <53 mm or >94 mm measured by CT
  2. Maximal ascending aortic diameter ≥50 mm
  3. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy
  4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).
  5. 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):

  1. Unprotected left main coronary artery disease ≥50%
  2. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is >2.5 mm
  3. Chronic total occlusion (CTO)
  4. Long lesion, expected stent length >38 mm
  5. Multivessel lesion (at least 2 coronary arteries require interventional treatment)
  6. Need to use multiple stents (planned > 3 stents)
  7. Lesion with in-stent restenosis
  8. Severe calcification lesion
  9. Coronary ostial lesion
  10. Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR.
• 19. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit
• 20. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit
• 21. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction <25%; or left ventricular end-systolic diameter (LVESD) >70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation.
• 22. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory
• 23. Cardiac imaging (echocardiography, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
• 24. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure
• 25. Uncontrolled atrial fibrillation (i.e., resting heart rate >120 bpm)
• 26. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022/ ACC 2020
• 27. Untread Leukopenia (WBC<3.0*109/L), Untread Thrombocytopenia (Platelet count <50*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin <9.0 g/dL)
• 28. Severe chronic obstructive pulmonary disease (COPD) (FEV1 <50% predicted) or currently on home oxygen
• 29. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2/3 systemic pressure)
• 30. Severe chronic liver disease (Child-Pugh C) or any active liver disease
• 31. Renal insufficiency (eGFR<30mL/min/1.73m²) and/or requiring chronic peritoneal dialysis at the time of screening and/or requiring chronic hemodialysis at the time of screening
• 32. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
• 33. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated
• 34. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
• 35. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy
• 36. BMI >50 kg/m2 or <18.5 kg/m2
• 37. Estimated life expectancy <24 months due to associated non- cardiac comorbid conditions
• 38. Immobility that would prevent completion of study procedures
• 39. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary
• 40. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
• 41. Pregnancy or intent to become pregnant (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study)
• 42. Other patients considered unsuitable for this clinical study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter aortic valve replacement (TAVR); Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system	Device: J-VALVE Transfemoral Aortic Valve system; Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system
Other: Surgical aortic valve replacement（SAVR）; Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device	Device: Commercially available surgical biological aortic valve replacement device; Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality at 12 months	12 months
All stroke	Number of patients with stroke	12 months
Unplanned cardiac rehospitalization	Number of patients who had unplanned cardiac rehospitalization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite primary endpoints	Comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR	30 days
New-onset atrial fibrillation	Comparing the onset of atrial fibrillation in TAVR with SAVR	30 days
Echocardiographic effective orifice area	Comparing echocardiographic effective orifice area in TAVR with SAVR	30 days
Moderate or greater patient prosthesis mismatch as measured by echocardiography	Comparing moderate or greater patient prosthesis mismatched in TAVR with SAVR	30 days
Cardiovascular rehospitalization	Comparing the number of cardiovascular rehospitalizations in TAVR with SAVR	30 days
Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)	Comparing change in KCCQ-23 in TAVR with SAVR.	30 days
Length of index hospitalization	Comparing TAVR length of index hospitalization with SAVR	Pre-intervention/procedure surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding complications (life-threatening, disabling, or major)	Comparing bleeding complications in TAVR with SAVR	30 days, 6 months and 1 year
Major adverse cardiovascular and cerebrovascular events (MACCE)	Freedom of major adverse cardiovascular and cerebrovascular events	years 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Mortality (all-cause & cardiovascular)	Comparing mortality (all-cause & cardiovascular in TAVR with SAVR	30 days,6 months and years 1, 5, 10
Stroke (disabling and nondisabling)	Comparing stroke (disabling and nondisabling) in TAVR with SAVR	30days, 6 months and years 1, 5, 10
Death or stroke	Comparing death or stroke in TAVR with SAVR	1 year
Death or disabling stroke	Comparing death or disabling strokein TAVR with SAVR	30 days, and 1 year
Major vascular complications	Comparing major vascular complications in TAVR with SAVR	30 days
Other procedural or valve-related complications	Comparing other procedural or valve-related complications in TAVR with SAVR	30 days
Technical success	Comparing technical success in TAVR with SAVR	Exit from procedure room
Device success	Comparing device success in TAVR with SAVR	30 days
Myocardial infarction	Comparing myocardial infarction in TAVR with SAVR	30 days, 6 months and 1 year
Coronary obstruction requiring intervention	Comparing coronary obstruction requiring intervention in TAVR with SAVR	30 days, 6 months and 1 year
Acute kidney injury	Comparing acute kidney injury in TAVR with SAVR	30 days
Renal replacement therapy	Comparing renal replacement therapy in TAVR with SAVR	1 year
New permanent pacemaker implantation	Comparing new permanent pacemaker implantation in TAVR with SAVR	30 days, 6 months and years 1, 5, 10
Conduction disturbance and arrhythmias	Comparing conduction disturbance and arrhythmias in TAVR with SAVR	30 days,6 months and 1 year
New York Heart Association class	Comparing change in New York Heart Association class in TAVR with SAVR	30 days, 6 months and years 1, 5, and 10
Hemodynamic valve performance evaluated by echocardiography	Comparing hemodynamic valve performance evaluated by echocardiography in TAVR with SAVR	30 days, 6 months and at years 1, 2, 3, 4, 5, 7, 10.
Other echocardiographic parameters	Comparing other echocardiographic parameters in TAVR with SAVR	30 days, and years 1, 2, 3, 4, 5, 7, 10.
Cardiovascular rehospitalization	Comparing cardiovascular rehospitalizations( the time to first event and number of events) in TAVR with SAVR	30 days, 6 months,1 year, and annually until 10 years
ICU days	Comparing ICU days in TAVR with SAVR	Time from immediate post-operation to ICU discharge
Redo valve replacement	Comparing redo valve replacement in TAVR with SAVR	30 days, 6 months,1 year, and annually until 10 years
Six-minute walk test	Comparing change in six-minute walk test in TAVR with SAVR	30 days,6 months, and 1year
Health-related Quality of Life as Assessed by KCCQ-23	Comparing change in KCCQ-23 in TAVR with SAVR	30 Days,6 months,1 year
Early safety	Comparing early safety in TAVR with SAVR	30 days
Clinical efficacy	Comparing clinical efficacy in TAVR with SAVR	1 year, and annually until 10 years
Valve related long-term clinical efficacy	Comparing valve related long-term clinical efficacy in TAVR with SAVR	5 years and thereafter until 10 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jian'an Wang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2038

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: RCT; TAVR; Aortic Regurgitation; SAVR
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: 20251693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No