NCT06034028

J-Valve TF Early Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

Detailed description

The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 25 subjects in up to 15 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.

Conditions

• Aortic Valve Disease
• Aortic Valve Insufficiency
• Aortic Regurgitation

Interventions

Type	Name	Description
DEVICE	J-Valve TF System	The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-07-17
• Completion: 2029-08-25
• First posted: 2023-09-13
• Last updated: 2025-07-11

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study