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RECRUITING
NCT07021612

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

Sponsor: Prince of Wales Hospital, Shatin, Hong Kong

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-04-01

Completion Date

2028-09-30

Last Updated

2025-06-15

Healthy Volunteers

Not specified

Interventions

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.

Locations (1)

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong