RecruitingNot ApplicableNCT07453407

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

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

1,250 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Insufficiency Aortic Insufficiency aortic regurgitation

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Commercially available surgical biological aortic valve replacement device and a medical device called J-VALVE Transfemoral Aortic Valve system for people with aortic insufficiency, aortic valve insufficiency, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEJ-VALVE Transfemoral Aortic Valve system

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

DEVICECommercially available surgical biological aortic valve replacement device

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

Locations(12)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Queen Mary Hospital

Hong Kong, Hong Kong, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Xijing Hospital affiliated to Air Force Medical University

Xi'an, Shaanxi, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Cheng Hsin General Hospital

Taibei, Taiwan, China

National Taiwan University Hospital

Taibei, Taiwan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07453407

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