NCT07453407

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	J-VALVE Transfemoral Aortic Valve system	Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system
DEVICE	Commercially available surgical biological aortic valve replacement device	Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

Timeline

• Start date: 2026-03-05
• Primary completion: 2029-03-01
• Completion: 2038-03-01
• First posted: 2026-03-06
• Last updated: 2026-03-10

Locations

12 sites across 1 country: China