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

Recruiting now

Conditions studied: Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT07021612

Run by

Prince of Wales Hospital, Shatin, Hong Kong

People needed

30

Starts

2025-04-01

Expected to finish

2028-09-30

Last updated by the study team

2025-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
• with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
• Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
• Capable of providing informed consent

You may not qualify if…

• Evidence of intracardiac mass, thrombus or vegetation
• Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
• Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
• Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
• Chronic Kidney Disease with eGFR <30 ml/min/1.73m2.
• Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
• Contraindicated for CT or MRI assessment

Where it is running

• Prince of Wales Hospital — Hong Kong, Shatin, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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