RecruitingNCT07021612

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


Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Enrollment

30 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called J-Valve and a medical device called JenaValve for people with aortic valve disease. The study is currently recruiting participants at 1 location.

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

DEVICEJenaValve

JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.

DEVICEJ-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

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NCT07021612


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