Actively Recruiting
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-10
1250
Participants Needed
12
Research Sites
625 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Symptomatic patients with severe aortic regurgitation (AR) or asymptomatic patients with severe AR and evidence of left ventricular function impairment
- Left ventricular ejection fraction (LVEF) 55% or less, or other specific measures of left ventricular size and function as detailed in guidelines
- Evaluated by a multidisciplinary heart team to be suitable for both surgery and transcatheter valve replacement
- Provided informed consent and agrees to comply with all required post-procedure follow-up visits
You will not qualify if you...
- Moderate or less severe aortic regurgitation (Grade 2 or below) by core laboratory evaluation
- Moderate or severe aortic valve stenosis
- Severe mitral or tricuspid valve disease requiring intervention
- Pre-existing mechanical or bioprosthetic valve in any position (mitral ring not excluded)
- High risk for surgical aortic valve replacement as determined by local heart team
- Refusal of surgical aortic valve replacement as treatment
- Selection for aortic valve repair or aortic surgery
- Need for emergency surgery or transcatheter valve replacement
- Anatomical exclusions including inappropriate aortic annulus size, large ascending aortic diameter, congenital aortic valve disease, unsuitable iliofemoral vessels, or significant aortic disease preventing safe procedure
- Hemodynamic or respiratory instability requiring support within 30 days of screening
- Recent cardiac resynchronization therapy device implantation
- Contraindications to mechanical circulatory support
- Hostile chest or prior surgery complications preventing safe reoperation
- Refusal of blood transfusion
- Connective tissue diseases requiring aortic root intervention
- Recent acute myocardial infarction or interventional procedures within 30 days
- Complex coronary artery disease as defined by several specific criteria
- Recent symptomatic carotid or vertebral artery disease or intervention
- Stroke or transient ischemic attack within 90 days
- Severe left ventricular dysfunction or mechanical heart support
- Moderate to severe right ventricular dysfunction
- Intracardiac mass, thrombus, or vegetation
- Left atrial thrombus without appropriate anticoagulation
- Uncontrolled atrial fibrillation
- Significant hypertrophic obstructive cardiomyopathy
- Blood disorders or bleeding risks
- Severe chronic lung or liver disease
- Renal insufficiency requiring dialysis
- Active infection or sepsis
- Hypersensitivity or contraindication to anticoagulation or implant materials
- Inability to tolerate antithrombotic therapy
- Active gastrointestinal bleeding
- BMI greater than 50 or less than 18.5 kg/m2
- Life expectancy less than 24 months due to non-cardiac conditions
- Immobility preventing study completion
- Current participation in other cardiovascular investigational studies without completed follow-up
- Severe cognitive decline impairing consent or compliance
- Pregnancy or intent to become pregnant
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
2
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
Prince of Wales Hospital
Hong Kong, Hong Kong, China, 999077
Not Yet Recruiting
5
Queen Mary Hospital
Hong Kong, Hong Kong, China, 999077
Not Yet Recruiting
6
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
7
Xijing Hospital affiliated to Air Force Medical University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
8
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
9
Cheng Hsin General Hospital
Taibei, Taiwan, China, 100-116
Not Yet Recruiting
10
National Taiwan University Hospital
Taibei, Taiwan, China, 100116
Not Yet Recruiting
11
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
12
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
J
Jian'an Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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