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

NCT07453407 | Recruiting DMC

• 1 other identifier: 20251693
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 12

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.

Conditions

Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency

Keywords

Aortic Regurgitation; TAVR; SAVR; RCT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• New-onset atrial fibrillation

  30 days

• Echocardiographic effective orifice area

  30 days

• Moderate or greater patient prosthesis mismatch as measured by echocardiography

  30 days

• Cardiovascular rehospitalization

  30 days

• Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)

  30 days

Other Outcomes (27)

• Bleeding complications (life-threatening, disabling, or major)

  30 days, 6 months and 1 year

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  years 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

• Mortality (all-cause & cardiovascular)

  30 days,6 months and years 1, 5, 10

Study Arms (2)

Transcatheter aortic valve replacement (TAVR)

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system

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

Device: Commercially available surgical biological aortic valve replacement device

Interventions

J-VALVE Transfemoral Aortic Valve system DEVICE

Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system

Transcatheter aortic valve replacement (TAVR)

Commercially available surgical biological aortic valve replacement device DEVICE

Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

Surgical aortic valve replacement（SAVR）

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \) Age ≥65 years；
• \) 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),
• \) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement
• \) 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:

• \. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation
• \. Moderate or severe aortic valve stenosis
• \. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention
• \. Subject is high-risk for SAVR as determined by the local heart team
• \. Subject refuses SAVR as a treatment option
• \. Subject is selected for aortic valve repair or aortic surgery
• \. Need for emergency surgery or TAVR for any reason
• 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.
• \. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit
• \. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit
• \. Any condition considered a contraindication to mechanical circulatory support

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (12)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong, 999077, China

NOT YET RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong, 999077, China

NOT YET RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Xijing Hospital affiliated to Air Force Medical University

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Cheng Hsin General Hospital

Taibei, Taiwan, 100-116, China

NOT YET RECRUITING

National Taiwan University Hospital

Taibei, Taiwan, 100116, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jian'an Wang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian'an Wang, MD

CONTACT

+86-571-8778-4808; wangjianan111@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2038
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)