Actively Recruiting
J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-10
1250
Participants Needed
12
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the J-VALVE Transcatheter Aortic Valve Replacement compared to traditional surgical aortic valve replacement in patients aged 65 and older with severe native aortic regurgitation. The study aims to understand which treatment option may be better suited for managing this heart valve condition by comparing outcomes such as mortality, stroke, and rehospitalization rates. Participants are randomly assigned to receive either the J-VALVE Transfemoral Aortic Valve system through a less invasive transcatheter procedure or a commercially available surgical biological aortic valve replacement device through open surgery. Both treatments are performed by specialized heart teams, and patients must be suitable candidates for either approach. The study includes a single-blind design to monitor outcomes objectively. During the trial, participants will be closely followed for one year to assess primary outcomes such as all-cause mortality, stroke, and unplanned cardiac rehospitalization. Additional assessments within the first 30 days include heart rhythm changes, valve function via echocardiography, and quality of life questionnaires. Researchers will also monitor hospital stay lengths and cardiovascular hospitalizations. Participants must attend follow-up visits and undergo evaluations to help measure the treatments' impacts and safety over time.
CONDITIONS
Brief 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 severe aortic regurgitation or asymptomatic with evidence of left ventricular function impairment
- Suitable for both surgical and transcatheter valve replacement as evaluated by a multidisciplinary heart team
- Provided informed consent and agrees to follow-up visits
You will not qualify if you...
- Moderate or less aortic regurgitation severity (Grade 2 or less)
- Moderate or severe aortic valve stenosis
- Severe mitral or tricuspid valve disease needing intervention
- Existing mechanical or bioprosthetic heart valve (except mitral ring)
- High risk for surgery or refusal of surgery
- Anatomical conditions like unsuitable aortic annulus size or vessel issues
- Recent major heart events, procedures, or strokes within specified timeframes
- Severe heart, lung, liver, or kidney dysfunction
- Conditions preventing safe anticoagulation or blood transfusion refusal
- Life expectancy under 24 months due to other diseases
- Severe cognitive impairment or inability to comply with study procedures
- Pregnancy or intent to become pregnant
- Participation in other cardiovascular investigational studies without completed follow-up
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until hospital discharge
Participants receive either transcatheter aortic valve replacement using the J-VALVE Transfemoral Aortic Valve system or surgical aortic valve replacement using a commercially available surgical biological aortic valve replacement device.
1 procedure visit and length of index hospitalization
Duration - Up to 12 months
Participants are monitored for outcomes including mortality, stroke, rehospitalization, and heart function for up to 12 months after the valve replacement procedure.
Regular follow-up visits over 12 months
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
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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