Aortic RegurgitationARTNCT07453407
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
A study testing J-VALVE Transfemoral Aortic Valve system and Commercially available surgical biological aortic valve replacement device in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- What is being tested?
- J-VALVE Transfemoral Aortic Valve system and Commercially available surgical biological aortic valve replacement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 28 sitesChina
- Study dates
- 5 Mar 2026to Mar 2038
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Chronic total occlusion (CTO)
- Long lesion, expected stent length >38 mm
- Multivessel lesion (at least 2 coronary arteries require interventional treatment)
- Need to use multiple stents (planned > 3 stents)
- Lesion with in-stent restenosis
- Severe calcification lesion
- Coronary ostial lesion
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites, 28 recruiting
- Not yet recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
Guangyuan Song, MD, +86-106-441-2431, songgy_anzhen@vip.163.com
Haibo Zhang, MD, +86-106-441-2431, zhanghb2318@163.com
- Not yet recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Xiangbin Pan, MD, +86-106-831-4466, xiangbin428@hotmail.com
- Not yet recruiting
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Zhenfei Fang, MD, +86-731-85295666, 2805955697@qq.com
Xiaobo Liao, MD, +86-731-85295666, baileyliaows@qq.com
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Fanyan Luo, MD, +86-731-89753999, Drlfy@csu.edu.cn
Lin Wang, MD, +86-731-89753999, Wanglin79922@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Zhong Wu, MD, +86-28-85422897, wuzhong71@scu.edu.cn
Jun Shi, MD, +86-28-85422897, shijun568@163.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Liangwan Chen, MD, +86-591-83357896, chenliangwan@fjmu.edu.cn
Xiaofu Dai, MD, +86-591-83357896, 1470054258@qq.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Huiming Guo, MD, +86-208-382-7812, guohuiming@gdph.org.cn
Jian Liu, MD, +86-20-83882222, jameslau1984@sina.com
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Liang Ma, MD, +86-571-8723-6114, 992960615@qq.com
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jian'an Wang, MD, +86-571-8731-5001, wangjianan111@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Chengxin Zhang, MD, +86-551-62922406, D201577709@126.com
- Not yet recruiting
Prince of Wales Hospital
Hong Kong, Hong Kong, 999077
Kent So, MD, +85-235-052-211, kentso987@gmail.com
- Not yet recruiting
Queen Mary Hospital
Hong Kong, Hong Kong, 999077
Simon Lam, MD, 852-2255, drsimonlam@gmail.com
- Not yet recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250000
Xinghua Gu, MD, +86-531-82166666, guxh2005@126.com
- Not yet recruiting
Kunming Yan'an Hospital
Kunming, Yunnan, 650000
Yayong Zhang, MD, +86-871-63211073, hyzkunming@163.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Yongbing Wu, MD, +86- 791-86120120, wuyingbing789@163.com
Renqiang Yang, MD, +86- 791-86120120, yangrenqiangcn@163.com
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Junjie Zhang, MD, +86-255-227-1000, jameszll@163.com
Xin Chen, MD, +86-25-52271000, stevecx@njmu.edu.cn
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Lei Jiang, MD, +86-532-82913225, Jianglei1126@sina.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
Xumin Hou, MD, +86-21-22200000, hxmchest@163.com
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Qi Zhang, MD, +86-21-38804518, zhangqnh@hotmail.com
Jun Liu, MD, +86-21-38804518, liujun52@126.com
- Not yet recruiting
Shanghai Geriatric Medical Center
Shanghai, Shanghai Municipality, 200000
Lai Wei, MD, +86-21-51371990, Wei.lai@zs-hospital.sh.cn
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Lai Wei, MD, +86-216-404-1990, Wei.lai@zs-hospital.sh.cn
- Not yet recruiting
Cheng Hsin General Hospital
Taibei, Taiwan, 100-116
Jeng Wei, MD, +86-228-264-400, jengwei@mac.com
- Not yet recruiting
National Taiwan University Hospital
Taibei, Taiwan, 100116
Hsien-Li Kao, MD, 022-312-3456, hsienli_kao@yahoo.com
- Not yet recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300000
Nan Jiang, MD, +86-22-23147117, jiangnantj@126.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Nanguo Dong, MD, +86-27-85726114, dongnianguo@hotmail.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Jinping Liu, MD, +86- 27-67812888, liujinping@znhospital.cn
- Not yet recruiting
Xijing Hospital affiliated to Air Force Medical University
Xi'an, Shaanxi, 710000
Jian Yang, MD, +86-298-477-4114, yangjian1212@hotmail.com
- Not yet recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Yiqiang Yuan, MD, +86-371 5868 0123, zzqyyuanyiqiang@126.com
About this study
Official title: 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.
- Being tested
- J-VALVE Transfemoral Aortic Valve system, Commercially available surgical biological aortic valve replacement device
- Keywords
- Aortic Regurgitation, TAVR, SAVR, RCT
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-VALVE Transfemoral Aortic Valve systemDevice
Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system
Commercially available surgical biological aortic valve replacement deviceDevice
Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter aortic valve replacement (TAVR) | Experimental | Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system Receives: Device: J-VALVE Transfemoral Aortic Valve system |
| Surgical aortic valve replacement（SAVR） | Other | Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device Receives: Device: Commercially available surgical biological aortic valve replacement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality at 12 months
Measured: 12 months
All stroke
Number of patients with stroke
Measured: 12 months
Unplanned cardiac rehospitalization
Number of patients who had unplanned cardiac rehospitalization
Measured: 12 months
Secondary outcomes (7)
New-onset atrial fibrillation
Comparing the onset of atrial fibrillation in TAVR with SAVR
Measured: 30 days
Echocardiographic effective orifice area
Comparing echocardiographic effective orifice area in TAVR with SAVR
Measured: 30 days
Moderate or greater patient prosthesis mismatch as measured by echocardiography
Comparing moderate or greater patient prosthesis mismatched in TAVR with SAVR
Measured: 30 days
Cardiovascular rehospitalization
Comparing the number of cardiovascular rehospitalizations in TAVR with SAVR
Measured: 30 days
Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
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.
Measured: 30 days
Length of index hospitalization
Comparing TAVR length of index hospitalization with SAVR
Measured: Pre-intervention/procedure surgery
Composite primary endpoints
Comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start5 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453407
- Sponsor's protocol ID
- 20251693
- Acronym
- ART
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No