NCT07021612

A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation

A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation: An Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery. TAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	JenaValve	JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
DEVICE	J-Valve	J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-03-31
• Completion: 2028-09-30
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study